Parietene PPM1510Recalls & reported problems
Sofradim Production · Macroporous Mesh, Monofilament Polypropylene · Class 2 · Implant
All models of Parietene (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521213753), received between Aug 28, 2025 and Aug 28, 2025 — classified as 2 malfunctions.
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 problems
- Hernia2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSABDOMINAL PREPERITONEAL (TAPP) BILATERAL INGUINAL HERNIA REPAIR INVOLVING TWO MESHES, ON THE RIGHT SIDE IT WAS REPORTED THAT THERE WAS A RECURRENCE 10 DAYS AFTER THE SURGERY.
Patient problems: Hernia
MAUDE report 22910201 ↗MalfunctionAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSABDOMINAL PREPERITONEAL (TAPP) BILATERAL INGUINAL HERNIA REPAIR INVOLVING TWO MESHES, ON THE RIGHT SIDE IT WAS REPORTED THAT THERE WAS A RECURRENCE 10 DAYS AFTER THE SURGERY.
Patient problems: Hernia
MAUDE report 22910200 ↗
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- 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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