Parietene DS PPDS3020Recalls & reported problems
Sofradim Production · Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking · Class 2 · Implant
All models of Parietene DS (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521553491), received between Jul 13, 2020 and Jun 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient Device Interaction Problem1
Patient problems
- Hernia2
- Obstruction/Occlusion2
- Pain2
- Adhesion(s)1
- Bowel Perforation1
- Granuloma1
- Injury1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, AND OBSTRUCTIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, DEBRIDEMENT, LYSIS OF ADHESIONS, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 22215191 ↗InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION, BOWEL PERFORATION, CHRONIC PAIN, RECURRENCE, WHITE PEDUNCULATED ATTACHMENT TO MESENTERY, AND GRANULOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, SACS EXCISED, REMOVAL OF WHITE PEDUNCULATED ATTACHMENT TO MESENTERY, AND MESH REMOVAL.
Patient problems: Bowel Perforation; Granuloma; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain
MAUDE report 10263822 ↗
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- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
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- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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