C-QUR TACSHIELD 31628Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862316285), received between Nov 28, 2018 and Oct 5, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 PAIN, HERNIA RECURRENCE, ADHESIONS, LYSIS OF ADHESIONS AND ADDITIONAL SURGERY. 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: Adhesion(s); Hernia; Pain

  MAUDE report 20378879 ↗
• InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 ABSCESS, PUSS, INFECTION, RECTUS HEMATOMA, PAIN, SCAR TISSUE, DISPLACED MESH, INCORPORATED MESH, INCISION AND DRAINAGE, ACUTE FEBRILE ILLNESS, WOUND THERAPY, WOUND VAC AND REVISION SURGERIES ON (B)(6) 2020. 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: Hematoma; Scar Tissue; Unspecified Infection

  MAUDE report 19702700 ↗
• InjuryFeb 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PLAINTIFF ALSO ALLEGEDLY EXPERIENCED LACK OF INCORPORATION, ABSCESS, DESEROSALIZATION, PURULENT FLUID, WADDED UP MESH AND PNEUMATOSIS.

  Patient problems: Adhesion(s); Bowel Perforation; Septic Shock

  MAUDE report 16414860 ↗
• InjuryNov 22, 2022Patient-Device Incompatibility; 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 CHRONIC PAIN, RECURRENCE, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, CHRONIC INFLAMMATION, ALLERGIC REACTION, ADHESIONS, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA FORMATION AND TISSUE DAMAGE. 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: Adhesion(s); Foreign Body Reaction; Hernia; Pain; Unspecified Infection

  MAUDE report 15845852 ↗
• InjuryNov 22, 2022Insufficient Device Problem Information; 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 REVISION SURGERY, ADHESIONS, INFECTION, CHRONIC PAIN PHYSICAL AND EMOTIONAL INJURIES. 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: Adhesion(s); Pain; Unspecified Infection

  MAUDE report 15845822 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem

  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 CONTINUED DRAINAGE FROM SINUS TRACT, PAIN, AND INFECTION. 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: Adhesion(s); Fistula; Pain; Unspecified Infection

  MAUDE report 15542441 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem

  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 ADDITIONAL SURGERY, INFECTED AND WADDED UP MESH, INCISION AND DRAINAGE OF INFECTED ABDOMINAL WALL ABSCESS WITH SUBFASCIAL EXTENSION, DRAINING SINUS, RECURRENT INCISIONAL HERNIA, REPAIRED WITH PLACEMENT OF NEW MESH, ADHESIONS, PAIN. SUTURE GRANULOMA, GRANULATION TISSUE, STAPH AUREUS, INFLAMMATION, DEBRIDEMENT AND SINUS TRACT. 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; Adhesion(s); Skin Infection

  MAUDE report 12465662 ↗
• InjuryNov 28, 2018Insufficient Device Problem Information

  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: Injury

  MAUDE report 8111764 ↗

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.