Parietene DS PPDS12 (UDI 10884521795389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521795389), received between Apr 13, 2023 and Jun 8, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 19, 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 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 23099676 ↗
• InjuryJun 20, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, BALLED UP MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, PRIMARY HERNIA REPAIR AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22301006 ↗
• MalfunctionMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE SURGEON MADE COMMENT ABOUT HAVING AN ISSUE WITH DELAMINATION IN THE PAST IN A VENTRAL HERNIA REPAIR CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833432 ↗
• MalfunctionJan 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC VENTRAL HERNIA, WHEN THE DEVICE WAS OPENED OUT FROM THE PACKAGE, THE PREFIXED SUTURES WERE SEPARATED. THE SUTURES WERE DAMAGED AND NOT FIXED WITH THE MESH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18547581 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17565501 ↗
• InjuryMay 11, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, RECURRENCE, DEFECTIVE MESH, FISTULOUS TRACT, INFLAMMATION, SCARIFICATION, PAIN, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TAKE DOWN OF FISTULA, AND HERNIA REPAIR.

  Patient problems: Abdominal Pain; Discomfort; Emotional Changes; Fistula; Hernia; Inflammation; Nausea; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16911594 ↗
• InjuryApr 13, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, MESH SEPARATION, DEFECTIVE MESH, RECURRENCE, ADHESIONS, PAIN, HEMATOMA, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Emotional Changes; Foreign Body Reaction; Hematoma; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16737113 ↗