Parietex TCM2020Recalls & reported problems
Sofradim Production · Lightweight Mesh Monofilament Polyester · Class 2 · Implant
All models of Parietex (73)
Data updated Oct 18, 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 10884521178892), received between Oct 19, 2018 and Mar 21, 2019 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Injury2
- Abdominal Distention1
- Corneal Pannus1
- Fluid Discharge1
- Hernia1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2019Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PANNUS, ABDOMINAL SEROMA, SEROUS FLUID COMING OUT OF THE SEROMA AND SIGNIFICANT BULGING OF VENTRAL HERNIA MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED SURGICAL REVISION WITH SUTURES USED TO STRENGTHEN IN THE REPAIR, PLACEMENT OF NEW MESH, PANNICULECTOMY ABDOMINAL WALL, FASCIAL PLICATION, EXCISION OF PSEUDO-BURSA AND MULTIPLE ABDOMINAL WALL HERNIA REPAIRS.
Patient problems: Abdominal Distention; Corneal Pannus; Fluid Discharge; Injury; Seroma
MAUDE report 8440366 ↗InjuryOct 19, 2018Adverse 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MULTIPLE RECURRENT INCISIONAL HERNIAS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INCISIONAL HERNIA REPAIRED WITH NEW MESH; ALL THE SMALL HERNIAS IN THE SKIN WERE NOTED AND THEY WERE DISSECTED AWAY FROM THE ANTERIOR ABDOMINAL WALL.
Patient problems: Hernia; Injury
MAUDE report 7985501 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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