ParieteneRecalls & reported problems across all models
Sofradim Production · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 243
- Deaths reported
- 2
- Injuries reported
- 235
- Recalls
- 0
We found 12 models of Parietene by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2017 and Aug 11, 2026 — classified as 2 deaths, 235 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (73 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Parietene problems
Device problems
- Adverse Event Without Identified Device or Use Problem237
- Mechanics Altered73
- Migration or Expulsion of Device52
- Patient Device Interaction Problem28
- Material Deformation13
- Insufficient Device Problem Information12
- Material Integrity Problem12
- Material Split, Cut or Torn10
Patient problems
- Unspecified Tissue Injury211
- Pain195
- Hernia193
- Adhesion(s)134
- Inflammation87
- Emotional Changes80
- Unspecified Infection72
- Scar Tissue62
Parietene models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Parietene PPM4530Mesh, surgical, polymeric2 deaths49 reports
- Parietene PPM3030Mesh, surgical, polymeric48 reports
- Parietene PPM1515X3Mesh, surgical, polymeric47 reports
- Parietene PPM1508X3Mesh, surgical, polymeric35 reports
- Parietene PPM1510X3Mesh, surgical, polymeric32 reports
- Parietene PPM2020Mesh, surgical, polymeric13 reports
- Parietene PPM1106X3Mesh, surgical, polymeric10 reports
- Parietene PPMK1508X3Mesh, surgical, polymeric3 reports
- Parietene PPM1510Mesh, surgical, polymeric2 reports
- Parietene PPMK1106X3Mesh, surgical, polymeric2 reports
- Parietene PPM1106Mesh, surgical, polymeric1 report
- Parietene PPM3030X3Mesh, surgical, polymeric1 report
Recent Parietene adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
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 the implant, the patient experienced abdominal pain, mesh migration, pain/suffering, severe emotional distress, disability, impairment, loss of enjoyment of life, loss of care, loss of comfort, defective mesh, mental pain, distress, and recurrence. Concomitant device: Protacker.
Patient problems: Abdominal Pain; Discomfort; Distress; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 50211968 ↗InjuryJul 30, 2026Adverse 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 pain, hernia recurrence, inflammation, obstruction, abdominal pain, constipation. Post-operative patient treatment included medication.
Patient problems: Abdominal Pain; Constipation; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 50089544 ↗InjuryJun 9, 2026Adverse 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 EMOTIONAL DISTRESS, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH MESH.
Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25446143 ↗InjuryMay 28, 2026Material Split, Cut or Torn
ACCORDING TO THE REPORTER, POST-OPERATIVE OF A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR PERFORMED ON (B)(6) 2022, IT WAS NOTED ON 15-MAY-2026 THAT THE MESH WAS FRACTURED AND HAD CAUSED A HERNIA RECURRENCE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REPAIR THE HERNIA RECURRENCE.
Patient problems: Hernia
MAUDE report 25312379 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
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 DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25296412 ↗InjuryMay 19, 2026Adverse 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 AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 25221381 ↗InjuryMay 19, 2026Adverse 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 25219872 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
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 DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS.
Patient problems: Adhesion(s); Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25186822 ↗InjuryApr 29, 2026Adverse 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 AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 25033341 ↗InjuryApr 7, 2026Adverse 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 RECURRENCE, PAIN.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24802013 ↗InjuryApr 7, 2026Adverse 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 PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24801789 ↗InjuryApr 3, 2026Adverse 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 BOWEL OBSTRUCTION, PAIN.
Patient problems: Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 24778898 ↗InjuryMar 31, 2026Adverse 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 AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24750020 ↗InjuryMar 23, 2026Adverse 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24664925 ↗InjuryMar 5, 2026Adverse 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 PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.
Patient problems: Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24520765 ↗
Other Sofradim Production products
All Sofradim Production devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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