Parietene DSRecalls & reported problems across all models
Sofradim Production · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 123
- Deaths reported
- 1
- Injuries reported
- 101
- Recalls
- 0
We found 12 models of Parietene DS by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 123 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Aug 7, 2026 — classified as 1 death, 101 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (24 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 DS problems
Device problems
- Adverse Event Without Identified Device or Use Problem116
- Mechanics Altered24
- Migration or Expulsion of Device15
- Insufficient Device Problem Information14
- Patient Device Interaction Problem10
- Material Split, Cut or Torn6
- Material Deformation3
- Degraded2
Patient problems
- Unspecified Tissue Injury66
- Pain65
- Hernia56
- Adhesion(s)44
- Abdominal Pain30
- Emotional Changes26
- Discomfort21
- Inflammation20
Parietene DS models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Parietene DS PPDS15Mesh, surgical, polymeric34 reports
- Parietene DS PPDS12Mesh, surgical, polymeric26 reports
- Parietene DS PPDS2015Mesh, surgical, polymeric1 death15 reports
- Parietene DS PPDS12Mesh, surgical, polymeric11 reports
- Parietene DS PPDS1510Mesh, surgical, polymeric9 reports
- Parietene DS PPDS2015Mesh, surgical, polymeric6 reports
- Parietene DS PPDS1510Mesh, surgical, polymeric6 reports
- Parietene DS PPDS15Mesh, surgical, polymeric5 reports
- Parietene DS PPDS2520Mesh, surgical, polymeric4 reports
- Parietene DS PPDS2520Mesh, surgical, polymeric4 reports
- Parietene DS PPDS3020Mesh, surgical, polymeric2 reports
- Parietene DS PPDS3530Mesh, surgical, polymeric1 report
Recent Parietene DS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a umbilical incisional hernia. It was reported that after the implant, the patient experienced recurrence, pain, mesh migration, failure of mesh to incorporate, acute cystitis, mesh failure, device defective, mental pain, suffering, disability, loss of enjoyment of life. Post-operative patient treatment included trigger point injections, medical treatment, revision surgery.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 50180407 ↗DeathJul 27, 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, infection, recurrence, inflammation, adhesions, abscess, sepsis, necrotic fascia and death. Post-operative patient treatment included wound VAC, excisional debridement of anterior abdominal wall fascia, pulse lavage of abdominal wall, incision and drainage of abscess, mesh removal, hernia repair with new mesh and hospitalization. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration.
Patient problems: Abscess; Adhesion(s); Hernia; Inflammation; Necrosis; Pain; Sepsis; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 50038121 ↗InjuryJul 27, 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 umbilical hernia. It was reported that after the implant, the patient experienced pain, hernia recurrence, inflammation, adhesions, abdominal pain, burning protrusion of belly button. Post-operative patient treatment included surgical intervention, medication.
Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Burning Sensation; Hernia; Inflammation; Pain; Unspecified Tissue Injury
MAUDE report 50020418 ↗InjuryJun 15, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED UNSPECIFIC ADVERSE EVENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 25505487 ↗InjuryJun 8, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, OBSTRUCTION, PAIN AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED ROBOTIC-ASSISTED LYSIS OF ADHESIONS, "NLO TUBE" PLACEMENT, MESH REVISION, HOSPITALIZATION.
Patient problems: Adhesion(s); Obstruction/Occlusion; Pain; Unspecified Tissue Injury
MAUDE report 25430786 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER 10 DAYS AFTER A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH, THE PATIENT WAS PRESUMED TO HAVE A BOWEL OBSTRUCTION. THERE WAS NO OBSTRUCTION, BUT INTRAOPERATIVE FINDINGS A LOT OF DILATED RED-LOOKING INTESTINES LIKE AN INFECTIOUS OR INFLAMMATORY STATE. THE MESH LOOKED FINE.
Patient problems: Inflammation; Tissue Breakdown
MAUDE report 25345828 ↗InjuryMay 12, 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 INCISIONAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, PAIN, SUFFERING, ABDOMINAL PAIN, EMOTIONAL INJURIES, AND MESH FAILED. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS, PARTIAL REMOVAL OF MESH, ADDITIONAL SURGERY, AND EMERGENCY APPENDECTOMY.
Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 25151078 ↗InjuryApr 13, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24860199 ↗InjuryApr 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.
Patient problems: Unspecified Tissue Injury
MAUDE report 24837985 ↗InjuryFeb 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 and e pigastric hernia. It was reported that after implant, the patient experienced abscess, adhesions, infection, abdominal pain, pain, suffering and emotional distress. Post-operative patient treatment included revision surgery, lysis of adhesions and mesh removal.
Patient problems: Abdominal Pain; Abscess; Adhesion(s); Distress; Pain; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 24393935 ↗MalfunctionFeb 11, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC UMBILICAL HERNIA REPAIR THROUGH INTRAPERITONEAL ONLAY MESH TECHNIQUE, AFTER INSERTION TO THE PATIENT, THE COLLAGEN LAYER PEELED OFF FROM THE POLYPROPYLENE MESH WHILE ORIENTING THE MESH TOWARDS THE 3CM HERNIA DEFECT. THE WOUND WAS CLOSED USING A SUTURE, AND FIXATION WAS ACHIEVED WITH 12 POINTS USING A TACKER. TO AVOID POST-OPERATIVE COMPLICATIONS, THE MESH WAS DISCARDED AND ANOTHER MESH OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318559 ↗InjuryFeb 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Distress; Unspecified Tissue Injury
MAUDE report 24274224 ↗InjuryFeb 5, 2026Migration or Expulsion of Device; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 24274171 ↗InjuryDec 17, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, ABDOMINAL DISTENTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.
Patient problems: Abdominal Distention; Adhesion(s); Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23830964 ↗InjuryDec 12, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Integrity Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH SHRINKAGE, MESH FAILURE, ADHESIONS, RECURRENCE, PAIN, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, MESH REVISION, HERNIA REPAIR WITH NEW MESH.
Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23794109 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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