C-QUR 31544Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00650862315448), received between Jun 17, 2016 and Jul 24, 2025 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K050311, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Appropriate 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 WAS IMPLANTED WITH AN C-QUR MESH. PLAINTIFF ALLEGEDLY EXPERIENCED ABSCESS, DEBRIDEMENT, PURULENCE, SMALL BOWEL ADHESIONS / ADHESIOLYSIS, STRANGULATED NECROTIC BOWEL, SMALL BOWEL RESECTION, INCIDENTAL APPENDECTOMY. 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)

  MAUDE report 22585245 ↗
• InjuryNov 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED THE PLAINTIFF ALSO ALLEGEDLY EXPERIENCED RECURRENCE OF HERNIA, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, EXCESSIVE AND CHRONIC INFLAMMATION, ALLERGIC REACTION, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA FORMATION, AND TISSUE DAMAGE.

  Patient problems: Adhesion(s); Constipation; Pain; Skin Inflammation/ Irritation

  MAUDE report 20718214 ↗
• 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 HERNIA RECURRENCE, INCARCERATED WITH A WITH A LOOP OF SMALL BOWEL, ADHESIONS, LYSIS OF ADHESIONS, INFLAMMATION, INCORPORATED MESH, NAUSEA AND VOMITING, REVISION SURGERY ON (B)(6) 2012 WITH NON ATRIUM MESH IMPLANTED, ADDITIONAL SURGERY, PAIN, AND ABDOMINAL WALL RECONSTRUCTION. 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 19702670 ↗
• 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 REVISION SURGERY ON (B)(6) 2023 FOR INCARCERATED HERNIA RECURRENCE, ADHESIONS, LYSIS OF ADHESIONS. 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

  MAUDE report 19701006 ↗
• InjuryJul 2, 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 BOWEL OBSTRUCTION, ADHESIONS, LYSIS OF ADHESIONS, RESECTION SMALL INTESTINE, LOOPS OF SMALL BOWEL ASCITES, ENTEROTOMY 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); Bowel Burn; Obstruction/Occlusion

  MAUDE report 19662616 ↗
• InjuryApr 2, 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 LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH IMPLANT. 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); Hernia; Pain

  MAUDE report 19029819 ↗
• InjuryApr 2, 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 LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED HERNIA RECURRENCE, ADHESIONS, LYSIS OF ADHESIONS, INCARCERATED, OMENTAL FAT, PAIN, ABDOMINAL BULGE, REVISION SURGERY ON (B)(6) 2016, NOTE: MESH SOAKED IN ANTIBIOTIC SOLUTION ¿ OFF LABEL USE 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); Hernia; Pain

  MAUDE report 19029801 ↗
• InjuryJul 18, 2023Appropriate 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 INFECTED MESH, ADDITIONAL SURGERY AND PAIN. 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 17347662 ↗
• InjuryJun 6, 2023Appropriate 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 PAIN AND SUFFERING, RECURRENCE, ADHESIONS, LOOPS OF THE SMALL BOWEL, INFECTION, AND MESHOMA. 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); Hernia; Unspecified Infection

  MAUDE report 17076352 ↗
• InjuryAug 11, 2022Patient-Device Incompatibility; Therapeutic or Diagnostic Output Failure

  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, HERNIA RECURRENCE, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, EXCESSIVE AND CHRONIC INFLAMMATION, ALLERGIC REACTION, ADHESIONS, EROSION, ABSCESS, FISTULA, GRANULOMATOUS RESPONSE, SEROMA, 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: Abscess; Adhesion(s); Foreign Body Reaction; Unspecified Infection

  MAUDE report 15212219 ↗
• InjuryJan 20, 2022Patient-Device Incompatibility

  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 PAIN AND SUFFERING, HERNIA REPAIR, ADHESIONS AND INFLAMMATION. 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; Skin Inflammation/ Irritation

  MAUDE report 13311245 ↗
• InjuryJan 13, 2022Patient-Device Incompatibility

  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, ABDOMINAL PAIN, ADHESIONS, AND LYSIS OF ADHESIONS. 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); Hernia; Pain

  MAUDE report 13256254 ↗
• InjuryDec 22, 2021Output 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 RECURRENCE, PAIN, AND SEROMA. 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); Hernia; Pain; Seroma

  MAUDE report 13067147 ↗
• InjuryOct 27, 2020Appropriate 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 PAIN, REVISION, RECURRENCE, SCARRING, INCARCERATION AND ADHESIONS. 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); Hernia

  MAUDE report 10744806 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem

  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: Hernia

  MAUDE report 10702442 ↗
• InjuryJul 27, 2020Appropriate 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 HERNIA, DRAINAGE, NON-HEALING WOUND, INFECTION, ADHESIONS, FIBROSE TISSUE, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, FAT NECROSIS AND ADDITIONAL REVISIONS, 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: Foreign Body Reaction; Inflammation; Necrosis

  MAUDE report 10330321 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem

  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 10261662 ↗
• MalfunctionApr 30, 2019Structural Problem

  HOSPITAL REPORTED THAT THEY WENT TO OPEN THE PACKAGE ON THE STERILE FIELD FOR SURGERY THE ONE SIDE OF THE PACKAGE WOULD NOT OPEN CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8566864 ↗
• InjuryAug 16, 2018Material Deformation

  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 PAIN, INFLAMMATION, MESH DEFORMATION, MESH REMOVAL, AN RECURRENT HERNIA REQUIRING ADDITIONAL SURGERIES. 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: Failure of Implant; Hernia; Inflammation; Pain

  MAUDE report 7790889 ↗
• InjuryJun 17, 2016Appropriate Device Problem Term/Code Not Available

  REPORT RECEIVED FROM PATIENT THAT SHE REQUIRED AN EXPLANT OF A MESH THAT WAS IMPLANTED SEVERAL YEARS EARLIER. SHE REPORTED A BULGE AT THE UMBILICUS AND STATED THAT A TYPE OF 'BOLT' WAS USED TO SECURE THE MESH AND THERE WERE FOUR OF THEM.

  Patient problems: No Information

  MAUDE report 5733270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050311, K151386. One submission often covers many models, so check the product and lot details in each record.

• Z-1937-2013 · Jul 19, 2013 · Terminated
  C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
• Z-1936-2013 · Jul 19, 2013 · Terminated
  C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.