Parietene DS PPDS15 (UDI 10884521553460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521553460), received between Jun 19, 2019 and Dec 11, 2025 — classified as 24 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, ALLERGIC REACTION, DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, EROSION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH ANASTOMOSIS, ABDOMINAL SCAR REVISION, WOUND VAC.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 23785565 ↗
• InjuryMay 23, 2023Adverse 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: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16986934 ↗
• InjuryMay 3, 2022Degraded; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 14269797 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, THE PATIENT PRESENTED WITH UPPER ABDOMINAL BULGE THAT HAD SLOWLY GOTTEN LARGER. COMPUTED TOMOGRAPHY (CT) SHOWED ABDOMINAL DIASTASIS OF THE RECTUS MUSCLES WITH A SMALL UMBILICAL HERNIA THREE MONTHS AFTER. IT WAS NOTED THAT THE MESH WAS STILL IMPLANTED AND NOT EXPLANTED.

  Patient problems: Abdominal Distention; Hernia; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 12719080 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL AND PELVIC PAIN AND NAUS EA/VOMITING. CT SCAN WAS PERFORMED AND IT REVEALED THAT A SMALL VENTRAL AND RIGHT INGUINAL HERNIA OCCURRED. NEW INFORMATION WAS PROVIDED THAT THE PATIENT HAS RECOVERED.

  Patient problems: Hernia; Nausea; Pain; Unintended Radiation Exposure; Vomiting

  MAUDE report 12456144 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO CLINICAL STUDY, POST-OPERATIVELY, PATIENT HAD HYPOKALEMIA DUE TO DIURESIS. THE PATIENT WAS HOSPITALIZED FOR ELEVEN(11) DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335095 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, THE PATIENT HAD HYPERKALEMIA IN SETTING OF HEART FAILURE WITH REDUCED EJECTION FRACTION. THE PATIENT WAS HOSPITALIZED FOR 15 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335089 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, THE PATIENT WAS HOSPITALIZED FOR 3 DAYS DUE TO ACUTE ON CHRONIC SYSTOLIC CONGESTIVE HEART FAILURE EXACERBATION. THE PATIENT WAS RECOVERING. THE RELATEDNESS ASSESSMENT WAS UNLIKELY WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335076 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, THE PATIENT HAD ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC END STAGE HEART FAILURE. THE PATIENT WAS HOSPITALIZED FOR 5 DAYS. THE ISSUE WAS NOT RESOLVED. THE RELATEDNESS ASSESSMENT WAS UNLIKELY WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335066 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, PATIENT HAD PULMONARY EDEMA. PATIENT WAS HOSPITALIZED FOR THREE(3) DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335043 ↗
• MalfunctionAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, THE PATIENT HAD HYPOXIA IN SETTING OF SEVERE FLUID OVERLOAD AND ACUTE ON CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION. THE PATIENT WAS HOSPITALIZED FOR 11 DAYS. THE PATIENT WAS RECOVERING. THE RELATED ASSESSMENT WAS UNLIKELY WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335041 ↗
• MalfunctionAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO CLINICAL STUDY, POST-OPERATIVELY, PATIENT EXPERIENCED URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332309 ↗
• MalfunctionAug 16, 2021Adverse 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 A CLINICAL STUDY, POST-OPERATIVELY, THE SUBJECT EXPERIENCED, AN ACUTE ON CHRONIC HEART FAILURE WITH REDUCED EJECTION FR ACTION. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. IT WAS NOTED THE MEDICAL COMPLICATIONS WERE NOT RELATED TO SURGICAL DEVICE OR PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329450 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 11 MONTHS POSTOPERATIVELY, THE PATIENT EXPERIENCED A RECURRENCE OF VENTRAL HERNIA.

  Patient problems: Hernia

  MAUDE report 12092580 ↗
• InjuryJun 18, 2021Adverse 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SMALL BOWEL OBSTRUCTION, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PARIETENE MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 12026139 ↗
• InjuryMay 14, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, INFLAMMATION, IMPAIRMENT, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, MESH FAILURE, HERNIA RECURRENCE, MESH DETACHMENT, ADHESIONS, HEMATOMA, ABSCESS, AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, AND REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Ascites; Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Pain; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 11828755 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING MASTECTOMY WITH BILATERAL ABDOMINAL PROCEDURE, THE FREE TISSUE TRANSFER RECONSTRUCTION LEFT BREAST RADIATION WAS RESULTED IN SEVERELY CONSTRICTED AND NECROTIC LEFT RECONSTRUCTED BREAST. PATIENT HOSPITALIZATION WAS EXTENDED FOR 2 DAYS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11662351 ↗
• MalfunctionMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED LOWER ABDOMINAL PAIN AT THE SURGERY SITE WHEN BENDING OR STRETCHING.

  Patient problems: Abdominal Pain

  MAUDE report 11590575 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 468 DAYS FOLLOWING A LAPAROSCOPIC PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN NEAR THE TRANSFASCIAL SUTURE AT THE INFERIOR END WHEN BENDING DOWN OR STRETCHING. IT WAS NOTED THAT THE ABDOMINAL PAIN WAS POSSIBLY CAUSED BY A GRANULOMA OF THE SUTURE AND THE PLAN IS TO REMOVE THE SUTURE. THE PATIENT WAS TREATED WITH MEDICATION.

  Patient problems: Abdominal Pain; Granuloma

  MAUDE report 11516209 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER LAPAROSCOPIC, THE PATIENT EXPERIENCE ABDOMINAL. SUTURE GRANULOMA WAS PLANNED TO REMOVE.

  Patient problems: Abdominal Pain

  MAUDE report 11407790 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VENTRAL HERNIA REPAIR, THE PATIENT EXPERIENCED ABDOMINAL PAIN.

  Patient problems: Abdominal Pain; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 11372796 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING VENTRAL HERNIA REPAIR, A SUPERFICIAL ABDOMINAL WALL ABSCESS WAS OBSERVED. THIS RESULTED TO PATI ENT EXTENDED HOSPITALIZATION.

  Patient problems: Abscess

  MAUDE report 11273103 ↗
• InjuryDec 28, 2020Mechanics 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OPEN DRAINING WOUND, INFECTION, ABSCESS, INFECTIOUS SINUS TRACT FROM THE SKIN DOWN INTO THE MESH, NECROSIS, AND MESH WAS EXPOSED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Decreased Appetite; Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Necrosis; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11078451 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RECURRENT UPPER ABDOMINAL BULGE THAT HAS SLOWLY GOTTEN LARGER OVER THE LAST SEVERAL MONTHS. CT SCAN CONFIRMED TO BE RECURRENT VENTRAL HERNIA.

  Patient problems: Hernia

  MAUDE report 10817580 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE MONTHS POSTOPERATIVE TO LAPAROSCOPIC VENTRAL HERNIA REPAIR, ABDOMINAL DIASTASIS WAS OBSERVED. THE PATIENT HAD RECURRENT UPPER ABDOMINAL BULGE THAT HAD SLOWLY GOTTEN LARGER OVER THE LAST SEVERAL MONTHS. CT SCAN CONFIRMED RECURRENT VENTRAL HERNIA.

  Patient problems: Hernia; Unintended Radiation Exposure

  MAUDE report 10795285 ↗