GORE MYCROMESH Biomaterial 1MYM08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132601547), received between Apr 12, 2019 and Nov 4, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON APPROXIMATELY (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY; TO BE SUPPLEMENTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9272622 ↗
• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2007, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY BOTH GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REVISION SURGERY, ABDOMINAL PAIN, MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abdominal Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9006464 ↗
• InjurySep 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2007, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY BOTH GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REVISION SURGERY, ABDOMINAL PAIN, MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abdominal Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9006462 ↗
• InjuryApr 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON AN UNKNOWN DATE, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FISTULA/SEROMA; INFECTION; INTESTINAL BLOCKAGE; REMOVAL SURGERY; REVISION SURGERY; SEVERE ABDOMINAL OR GROIN PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Seroma; Unspecified Infection

  MAUDE report 8511901 ↗