C-QUR V-PATCH 31200Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00650862312003), received between Jul 7, 2016 and Jul 22, 2025 — classified as 52 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K090909, 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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 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 V-PATCH MESH. PLAINTIFF ALLEGEDLY EXPERIENCED ABDOMINAL MASS/UMBILICAL MASS, INFECTION, INCARCERATION, DRAINAGE, SCAR TISSUE, INFLAMMATION, FOREIGN BODY REACTION, FIBROSIS. 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: Fibrosis; Foreign Body Reaction; Inflammation; Unspecified Infection

  MAUDE report 22563303 ↗
• InjuryOct 17, 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, INCARCERATION, DIASTASIS RECTI, PAIN, ADHESIONS, LYSIS OF ADHESIONS, BALLED MESH 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

  MAUDE report 20472408 ↗
• 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 RECURRENT HERNIA, REVISION, ADHESIOLYSIS, SMALL BOWEL RESECTION, PAIN, SCAR TISSUE, ENTEROTOMY, ADHESIONS, INCARCERATED 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 19700912 ↗
• InjuryMay 28, 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 INCARCERATED, ADHESIONS, INFLAMMATION, LYSIS OF ADHESIONS, BUCKLED MESH, NECROTIC FIBROADIPOSE TISSUE WITH CALCIFICATIONS 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 19410525 ↗
• 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: Insufficient Information

  MAUDE report 19029818 ↗
• 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 REVISION SURGERY ON (B)(6) 2019 FOR NONHEALING WOUND, STITCH ABSCESS, CHRONIC INFLAMMATION, ALSO HERNIA RECURRENCE, UNINCORPORATED MESH, AND ADDITIONAL 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; Skin Inflammation/ Irritation

  MAUDE report 19029817 ↗
• 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 ADHESIONS, PAIN, RECURRENCE, SCAR TISSUE AND ADDITIONAL 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: Adhesion(s); Hernia; Pain

  MAUDE report 19029798 ↗
• 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: Insufficient Information

  MAUDE report 19029797 ↗
• InjuryFeb 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PLAINTIFF ALSO ALLEGEDLY EXPERIENCED INCARCERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia

  MAUDE report 16427880 ↗
• InjuryJan 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PLAINTIFF ALSO ALLEGEDLY EXPERIENCED NON-HEALING WOUND, DEBRIDEMENT AND CHRONIC DRAINING SINUS TRACT.

  Patient problems: Abscess; Hernia; Pain

  MAUDE report 16204838 ↗
• InjuryDec 4, 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 PAIN, ADHESIONS, HERNIA RECURRENCE, BLOATING, CONSTIPATION AND ADDITIONAL 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: Adhesion(s); Hernia; Pain

  MAUDE report 15912536 ↗
• InjuryDec 4, 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, ADHESIONS, HERNIA RECURRENCE AND ADDITIONAL 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: Adhesion(s); Hernia; Pain

  MAUDE report 15912449 ↗
• InjuryOct 26, 2022Migration or Expulsion of Device; 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 SEVERE ABDOMINAL PAIN, DIGESTIVE PROBLEMS, SCAR TISSUE, RECURRENCE, FAILURE TO INCORPORATE, AND MESH MIGRATION. 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; Scar Tissue

  MAUDE report 15677920 ↗
• InjurySep 29, 2022Material 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 CHRONIC PAIN, EXTENSIVE LYSIS OF ADHESIONS, HERNIA RECURRENCE, MESH FOLDING AND ADDITIONAL 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: Adhesion(s); Hernia; Pain

  MAUDE report 15508871 ↗
• InjuryAug 11, 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 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; Skin Infection; Unspecified Infection

  MAUDE report 15215065 ↗
• InjuryAug 11, 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 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 15215041 ↗
• 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, TISSUE DAMAGE AND ADDITIONAL SURGERY ON (B)(6) 2015. 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; Scar Tissue; Unspecified Infection

  MAUDE report 15212383 ↗
• InjuryAug 9, 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 CHRONIC PAIN, ADHESIONS, HERNIA RECURRENCE AND ADDITIONAL 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: Adhesion(s); Hernia; Obstruction/Occlusion; Pain

  MAUDE report 15196402 ↗
• InjuryJul 5, 2022Physical Resistance/Sticking

  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, DIGESTIVE PROBLEMS, SCAR TISSUE, INFECTION, ABSCESS, ADHESIONS, DEBRIDEMENT AND ADDITIONAL 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; Adhesion(s); Unspecified Infection

  MAUDE report 14914765 ↗
• InjuryJul 5, 2022Physical Resistance/Sticking

  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, DIGESTIVE PROBLEMS, SCAR TISSUE, INFECTION, MESH REMOVAL, WOUND VAC TREATMENT, ADHESIONS, DEBRIDEMENT OF THE SKIN AND 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: Adhesion(s); Pain; Unspecified Infection

  MAUDE report 14914660 ↗
• InjuryJun 26, 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 CHRONIC PAIN, RECURRENCE, FOREIGN BODY RESPONSE, REJECTION, INFECTION, FAILURE OF INCORPORATION/INGROWTH, SCARIFICATION, IMPROPER WOUND HEALING, 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; Foreign Body Reaction; Unspecified Infection

  MAUDE report 14822780 ↗
• InjuryJun 16, 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 ABDOMINAL ADHESIONS, PAIN AND REVISION SURGERY IN (B)(6) 2021. 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

  MAUDE report 14723753 ↗
• InjuryApr 29, 2022Material Protrusion/Extrusion

  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, INFECTION, EXTRUSION OF MESH THROUGH FASCIA AND BLEEDING. 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; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 14256793 ↗
• InjuryMar 10, 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 FLUID COLLECTION, ABSCESS, FISTULA, ADHESIONS TO SMALL BOWEL, AND HAIR LOSS. 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); Fistula

  MAUDE report 13724599 ↗
• 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 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: Hernia; Insufficient Information; Pain

  MAUDE report 13256518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090909, K151386. One submission often covers many models, so check the product and lot details in each record.

• Z-1938-2013 · Jul 19, 2013 · Terminated
  C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.