PMID- 25637208
OWN - NLM
STAT- MEDLINE
DCOM- 20161114
LR  - 20240322
IS  - 1943-4723 (Electronic)
IS  - 0002-8177 (Print)
IS  - 0002-8177 (Linking)
VI  - 146
IP  - 2
DP  - 2015 Feb
TI  - The dangers of dental devices as reported in the Food and Drug Administration 
      Manufacturer and User Facility Device Experience Database.
PG  - 102-10
LID - S0002-8177(14)00025-7 [pii]
LID - 10.1016/j.adaj.2014.11.015 [doi]
AB  - BACKGROUND: The authors conducted a study to determine the frequency and type of 
      adverse events (AEs) associated with dental devices reported to the Food and Drug 
      Administration Manufacturer and User Facility Device Experience (MAUDE) database. 
      METHODS: The authors downloaded and reviewed the dental device-related AEs 
      reported to MAUDE from January 1, 1996, through December 31,2011. RESULTS: MAUDE 
      received a total of 1,978,056 reports between January 1, 1996, and December 31, 
      2011. Among these reports, 28,046 (1.4%) AE reports were associated with dental 
      devices. Within the dental AE reports that had event type information, 17,261 
      reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. 
      Among the 66 entries classified as death reports, 52 reported a death in the 
      description; the remaining were either misclassified or lacked sufficient 
      information in the report to determine whether a death had occurred. Of the 
      dental device-associated AEs, 53.5% pertained to endosseous implants. 
      CONCLUSIONS: A plethora of devices are used in dental care. To achieve Element 1 
      of Agency for Healthcare Research and Quality's Patient Safety Initiative, 
      clinicians and researchers must be able to monitor the safety of dental devices. 
      Although MAUDE was identified by the authors as essentially the sole source of 
      this valuable information on adverse events, their investigations led them to 
      conclude that MAUDE had substantial limitations that prevent it from being the 
      broad-based patient safety sentinel the profession requires. PRACTICAL 
      IMPLICATIONS: As potential contributors to MAUDE, dental care teams play a key 
      role in improving the profession's access to information about the safety of 
      dental devices.
CI  - Copyright (c) 2015 American Dental Association. Published by Elsevier Inc. All 
      rights reserved.
FAU - Hebballi, Nutan B
AU  - Hebballi NB
FAU - Ramoni, Rachel
AU  - Ramoni R
FAU - Kalenderian, Elsbeth
AU  - Kalenderian E
FAU - Delattre, Veronique F
AU  - Delattre VF
FAU - Stewart, Denice C L
AU  - Stewart DC
FAU - Kent, Karla
AU  - Kent K
FAU - White, Joel M
AU  - White JM
FAU - Vaderhobli, Ram
AU  - Vaderhobli R
FAU - Walji, Muhammad F
AU  - Walji MF
LA  - eng
GR  - R01 DE022628/DE/NIDCR NIH HHS/United States
GR  - R01DE022628/DE/NIDCR NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - England
TA  - J Am Dent Assoc
JT  - Journal of the American Dental Association (1939)
JID - 7503060
SB  - IM
MH  - Databases, Factual
MH  - Dental Equipment/*adverse effects
MH  - Dental Instruments/*adverse effects
MH  - Humans
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC4313571
MID - NIHMS643672
OTO - NOTNLM
OT  - Dental equipment
OT  - dental public health
OT  - dental records
OT  - informatics
OT  - quality of care
OT  - safety management
EDAT- 2015/02/01 06:00
MHDA- 2016/11/15 06:00
PMCR- 2016/02/01
CRDT- 2015/02/01 06:00
PHST- 2014/07/01 00:00 [received]
PHST- 2014/10/29 00:00 [revised]
PHST- 2014/11/07 00:00 [accepted]
PHST- 2015/02/01 06:00 [entrez]
PHST- 2015/02/01 06:00 [pubmed]
PHST- 2016/11/15 06:00 [medline]
PHST- 2016/02/01 00:00 [pmc-release]
AID - S0002-8177(14)00025-7 [pii]
AID - 10.1016/j.adaj.2014.11.015 [doi]
PST - ppublish
SO  - J Am Dent Assoc. 2015 Feb;146(2):102-10. doi: 10.1016/j.adaj.2014.11.015.