C-QUR TACSHIELD 31636Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00650862316360), received between Aug 27, 2020 and May 24, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100076, K151386); they may or may not involve this specific model.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PLAINTIFF ALSO ALLEGEDLY EXPERIENCED DEBRIDEMENT AND WOUND VAC PLACEMENT.

  Patient problems: Bowel Perforation; Wound Dehiscence

  MAUDE report 16993982 ↗
• InjuryDec 4, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED ABSCESS, ABDOMINAL PAIN, INFECTION AND REVISION SURGERY. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: Abscess; Hernia; Pain

  MAUDE report 15912538 ↗
• InjuryNov 19, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED INFECTION, ABSCESS, AND SMALL BOWEL OBSTRUCTION, SEVERAL REVISION PROCEDURES, SMALL BOWEL RESECTION AND PAIN AND MENTAL ANGUISH . SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: Abscess; Obstruction/Occlusion; Pain

  MAUDE report 15830739 ↗
• InjuryMay 31, 2022Appropriate Device Problem Term/Code Not Available

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED SEVERE ABDOMINAL PAIN, MESH INFECTION, HERNIA RECURRENCE, REVISION SURGERY, AND LIMITATIONS ON PHYSICAL ACTIVITY. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: Hernia; Pain; Unspecified Infection

  MAUDE report 14556301 ↗
• InjuryAug 27, 2020Patient-Device Incompatibility

  THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH IMPLANT. SINCE THIS IS A POTENTIAL LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/ CLIENT AND/ OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

  Patient problems: No Information

  MAUDE report 10463705 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100076, K151386. One submission often covers many models, so check the product and lot details in each record.

• Z-1939-2013 · Jul 19, 2013 · Terminated
  C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.