PMID- 38467236
OWN - NLM
STAT- Publisher
LR  - 20240330
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 149
DP  - 2024 Mar 11
TI  - Medical device report analyses from MAUDE: Device and patient outcomes, adverse 
      events, and sex-based differential effects.
PG  - 105591
LID - S0273-2300(24)00032-1 [pii]
LID - 10.1016/j.yrtph.2024.105591 [doi]
AB  - Post-market medical device-associated failures and patient problems are reported 
      in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports 
      are accessible through Manufacturer and User Facility Device Experience (MAUDE), 
      a database including both required and voluntary submissions. We present an 
      overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of 
      reporting issues represent medical device physical or functional failures, 
      categorized from 1704 codes related to medical device integrity or function.  approximately 8% 
      were coded adverse events (AEs). Patient outcomes are reported via 998 patient 
      codes in 19 medical specialties (cardiovascular, orthopedic, etc.).  approximately 40% of 
      patient reports indicated "no health consequences"; however, a small number of 
      devices had consistently high AE reports. While overall reports did not exhibit a 
      sex-based dichotomy,  approximately 9% of the reported AEs occurred more frequently in females, 
      many of which were related to immune effects. The analyses are subject to 
      uncertainties and potential bias based on data available and data selected for 
      analysis. However, such an overview of post-market MDR data, not previously 
      published, fills a gap in understanding medical device issues and patient-based 
      outcomes related to medical device use. Trends identified may be subjects of 
      additional hypotheses, analysis, and research.
CI  - Copyright (c) 2024. Published by Elsevier Inc.
FAU - Liao, Tsung-Jen
AU  - Liao TJ
AD  - Office of Research, National Center for Toxicological Research, US Food and Drug 
      Administration, Jefferson, AR, 72079, USA.
FAU - Crosby, Lynn
AU  - Crosby L
AD  - Office of Science and Engineering Laboratories, Center for Devices and 
      Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, 
      Silver Spring, MD, 20993, USA.
FAU - Cross, Kevin
AU  - Cross K
AD  - Instem, Inc., Columbus, OH, 43217, USA.
FAU - Chen, Minjun
AU  - Chen M
AD  - Office of Research, National Center for Toxicological Research, US Food and Drug 
      Administration, Jefferson, AR, 72079, USA.
FAU - Elespuru, Rosalie
AU  - Elespuru R
AD  - Office of Science and Engineering Laboratories, Center for Devices and 
      Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, 
      Silver Spring, MD, 20993, USA. Electronic address: rosalie.elespuru@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20240311
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
SB  - IM
OTO - NOTNLM
OT  - MAUDE
OT  - Medical devices
OT  - Patient outcomes
OT  - Post-market assessment
OT  - Women's health
COIS- Declaration of competing interest The authors declare no special interests or 
      competing interests in relation to this work and no use of AI in the work.
EDAT- 2024/03/12 00:42
MHDA- 2024/03/12 00:42
CRDT- 2024/03/11 20:13
PHST- 2023/09/30 00:00 [received]
PHST- 2024/02/09 00:00 [revised]
PHST- 2024/02/21 00:00 [accepted]
PHST- 2024/03/12 00:42 [pubmed]
PHST- 2024/03/12 00:42 [medline]
PHST- 2024/03/11 20:13 [entrez]
AID - S0273-2300(24)00032-1 [pii]
AID - 10.1016/j.yrtph.2024.105591 [doi]
PST - aheadofprint
SO  - Regul Toxicol Pharmacol. 2024 Mar 11;149:105591. doi: 
      10.1016/j.yrtph.2024.105591.