GORE MYCROMESH PLUS Biomaterial 1MYMP18Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132601721), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Hernia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE IN A LEGAL COMPLAINT THAT THE PATIENT UNDERWENT INGUINAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2002, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE LEGAL COMPLAINT ALLEGES THAT ON (B)(6) 2021, PLAINTIFF UNDERWENT EXPLORATORY SURGERY IN WHICH THE DEVICE WAS REMOVED. AS STATED IN THE LEGAL COMPLAINT, THE PATIENT ALLEGES THE FOLLOWING INJURIES: ¿RECURRING HERNIAS, RECURRING INGUINAL PAIN, ENLARGED GENITOFEMORAL AND ILIOHYPOGASTRIC NERVES, NUMEROUS SURGERIES, REMOVAL OF THE EPTFE MESH, AND ONGOING DISABILITY¿ AS WELL AS ¿DYSPAREUNIA AND SEXUAL DYSFUNCTION¿ AND THICKENING ¿HETEROGENEOUS HYPOECHOIC SOFT TISSUE ADJACENT TO THE SPERMATIC CORD.¿ ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hernia; No Clinical Signs, Symptoms or Conditions
MAUDE report 17492180 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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