Parietene DS PPDS2015 (UDI 10884521553477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521553477), received between Aug 25, 2019 and Jul 27, 2026 — classified as 1 death, 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 16, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, AND OBSTRUCTIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 22215253 ↗
• InjuryMar 10, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, DEFECTIVE DEVICE, SUFFERING, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ABDOMINAL PAIN, ADHESIONS, RECURRENCE, PAIN, MENTAL PAIN, AND DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, AND MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16522597 ↗
• InjuryNov 8, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SEROMA, FLUID COLLECTION, PAIN, INFLAMMATORY RESPONSE, DISCOMFORT, MENTAL ANGUISH, IMPAIRMENT OF DAILY LIVING, DEVICE DEFECTIVE, SUFFERING, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, FLUID COLLECTION ASPIRATION, INCISION AND DRAINAGE OF ABDOMINAL WALL WOUND.

  Patient problems: Ascites; Discomfort; Distress; Emotional Changes; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 15756356 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, FOLLOWING A VENTRAL HERNIA REPAIR, THE PATIENT EXPERIENCED POST- OPERATIVE EMESIS ON LIQUID DIET, INABILITY TO TOLERATE LIQUID DIET. COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS ORDERED AND REVEALED SLIGHT ILEUS. THE ILEUS OCCURRED 7 DAYS AFTER THE PROCEDURE. NO OBVIOUS CAUSE PRESENT ON CT SCAN. PATIENT IMPROVED FOLLOWING ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PERFORMED FOR TREATMENT OF ESOPHAGEAL STRICTURE. THE PATIENT WAS HOSPITALIZED FOR 12 DAYS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Unintended Radiation Exposure; Vomiting

  MAUDE report 14283910 ↗
• MalfunctionMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A CLINICAL STUDY, ON 24 MONTH FOLLOW-UP VISIT, THE PATIENT COMPLAINED OF PAIN AROUND THE SITE OF HERNIA REPAIR.

  Patient problems: Pain

  MAUDE report 13942567 ↗
• MalfunctionApr 5, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE PATIENT HAD COMPLAINTS OF PAIN AT SITE OF REPAIR, MAINLY AROUND THE EDGES OF THE MESH. CT SCAN WAS CONDUCTED AND SHOWED NO EVIDENCE OF RECURRENCE OF HERNIA, HOWEVER, IT WAS FOUND THAT THE SUBJECT HAS 2.6 CM LESION IN THE INTERPOLAR REGION OF THE LEFT KIDNEY WHICH WAS NOT DEVICE-RELATED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 11613538 ↗
• InjuryMar 19, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, INFECTION, INFLAMMATION, MESH MIGRATION, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE AND DEFECTIVE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH INTERVENTION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Aspiration Pneumonitis; Bacterial Infection; Bone Fracture(s); Confusion/ Disorientation; Electrolyte Imbalance; Emotional Changes; Erythema; Fever; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Nodule; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Swelling/ Edema; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11527302 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-LAPAROSCOPIC HERNIA REPAIR, THE PATIENT REPORTED PAIN AT SIGHT OF REPAIR, MAINLY AROUND THE EDGES OF THE MESH DEVICE. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS CONDUCTED WHICH SHOWED NO EVIDENCE OF RECURRENCE OF THE PATIENT'S HERNIA. HOWEVER, IT WAS FOUND THAT PATIENT HAS A LESION IN THE INTERPOLAR REGION OF THE LEFT KIDNEY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 11527194 ↗
• InjuryNov 25, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-OPERATIVE ON A HERNIA PROCEDURE, WHILE RE-OPERATING IT WAS FOUND OUT THAT THE MESH FRACTURED IN THE MIDLINE. THE BOWEL WAS HERNIATING THROUGH THE MIDLINE DEVICE FRACTURED AND THE BOWEL WAS DENSELY ADHERENT TO THE MESH.

  Patient problems: Hernia

  MAUDE report 10905014 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE LAST (B)(6) 2020. POST-OPERATIVELY ON (B)(6) 2020, THE PATIENT COMPLAINT OF ALLERGIC REACTION ON THE ABDOMEN. IT WAS NOTED THAT THERE WERE VISIBLE RASHES. THE PATIENT WAS GIVEN STEROIDS TO AID WITH THE ALLERGY. IT WAS ALSO REPORTED THAT THE WOUND IRRITATION CONTINUED SO THE SURGEON REQUESTED FOR A COMPUTERIZED TOMOGRAPHY SCAN.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 10835496 ↗
• MalfunctionAug 28, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE MESH WAS FRACTURED.

  Patient problems: No Information

  MAUDE report 10467348 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT EXPERIENCED RECURRENT ABDOMINAL BULGING AND DISCOMFORT 258 DAYS POST-OPERATIVE. A COMPUTERIZED TOMOGRAPHY (CT) SCAN SHOWS A RE-CURRENT VENTRAL HERNIA IN THE PERIUMBILICAL REGION RESULTING IN RE-OPERATION AND EXTENDED HOSPITALIZATION FOR FOUR MORE DAYS.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 10393069 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 16 DAYS POSTOPERATIVE, ERYTHEMA WAS OBSERVED ALONG THE LOWER ABDOMEN.

  Patient problems: Erythema

  MAUDE report 9693538 ↗
• InjuryAug 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, THE PATIENT EXPERIENCED CONTINUAL NUMBNESS AROUND HIS UMBILICUS, RECTUS SHEATH HEMATOMA AND INTERMITTENT ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH IV PAIN MEDICATION THAT WAS THEN TRANSITIONED TO ORAL MEDICATION. ON FIRST MONTH FOLLOW UP VISIT, THE PATIENT REPORTS THAT PAIN IS STILL ONGOING.

  Patient problems: Abdominal Pain; Hematoma; Numbness; Pain

  MAUDE report 8928869 ↗