Parietex TECR1510ALRecalls & reported problems
Sofradim Production · Hydrophilic Anatomical Mesh, Left Side, Polyester · Class 2 · Implant
All models of Parietex (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521180192), received between Aug 19, 2021 and Aug 19, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Mechanics Altered1
Patient problems
- Deformity/ Disfigurement1
- Emotional Changes1
- Failure of Implant1
- Fatigue1
- Hernia1
- Pain1
- Scar Tissue1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2021Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; Mechanics Altered; 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BROKEN DOWN MESH, FAILURE OF MESH, DEFECTIVE MESH, HERNIA RECURRENCE, PAIN, SCARRING, DISFIGUREMENT, FATIGUE, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND LOSS OF MENTAL AND EMOTIONAL HEALTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Deformity/ Disfigurement; Emotional Changes; Failure of Implant; Fatigue; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury
MAUDE report 12344855 ↗
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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