Parietene DS PPDS12 (UDI 10884521553446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521553446), received between Jul 24, 2018 and May 12, 2026 — classified as 23 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 20, 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, ADHESIONS, RECURRENCE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, MESH REVISION.

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

  MAUDE report 22856981 ↗
• InjuryFeb 20, 2024Adverse 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, SWELLING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 18740847 ↗
• InjuryJul 21, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, DISCOMFORT, RECURRENCE, ADHESIONS, ABDOMINAL PAIN, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL/OMENTIM WERE DISSECTED AND REDUCED, COMPONENT SEPARATION.

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

  MAUDE report 17373399 ↗
• InjuryMay 5, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MENTAL PAIN, PAIN, IMPAIRMENT, LOSS OFENJOYMENT OF LIFE, DISABILITY, ABDOMINAL PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16880130 ↗
• InjuryApr 27, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, TAKEDOWN OF ADHESIONS.

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

  MAUDE report 16826188 ↗
• InjuryNov 4, 2022Migration 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, HERNIA RECURRENCE, BLEEDING, SCAR TISSUE, BULGE IN STOMACH AREA, DIFFICULTY LIFTING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15739809 ↗
• InjuryJan 7, 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 HERNIA PROCEDURE, THERE WAS A REOCCURRENCE OF HERNIA THAT WAS DIAGNOSED DURING THE 24 MONTHS FOLLOW-UP VISIT.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 13193782 ↗
• InjuryAug 26, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, FAILURE OF MESH, PAIN, SCARRING, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND PLACEMENT OF ADDITIONAL MESH.

  Patient problems: Failure of Implant; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12374423 ↗
• InjuryMar 26, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, ADMISSION TO HOSPITAL, AND ADHESIONS TAKEN OFF MESH.

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

  MAUDE report 11577364 ↗
• InjuryMar 19, 2021Migration 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, THICKENING OF SMALL BOWEL, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH INTERVENTION SURGERY AND REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Discomfort; Emotional Changes; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury; Weight Changes

  MAUDE report 11527348 ↗
• InjuryOct 27, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OMENTAL ADHESIONS TO THE MESH, CHRONIC ABDOMINAL PAIN, CHRONIC PAIN, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Injury; Pain

  MAUDE report 10741745 ↗
• InjuryOct 1, 2020Adverse 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 HERNIA AND AN UMBILICAL HERNIA IN LAPAROSCOPIC REPAIR. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SEROMA, RECURRENCE, FLUID COLLECTION, PAIN, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND HERNIA REPAIR.

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

  MAUDE report 10617463 ↗
• InjuryAug 21, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, AND MESH EVENTRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 10439767 ↗
• MalfunctionFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST-OPERATIVE A HERNIA REPAIR PROCEDURE THE PATIENT DESCRIBES A FEELING A PULLING SENSATION AT THE SURGICAL SITE. THE PATIENT FELT DISCOMFORT. THERE WAS NO PATIENT HARM.

  Patient problems: Discomfort; No Consequences Or Impact To Patient

  MAUDE report 9732161 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED A SMALL SEROMA AND UMBILICUS ONE MONTH POST OPERATIVE.

  Patient problems: Seroma

  MAUDE report 9659917 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED SMALL SEROMA. THE PATIENT RECOVERED FROM THE COMPLICATION.

  Patient problems: Seroma

  MAUDE report 8974935 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A SMALL SEROMA FOLLOWING A VENTRAL HERNIA REPAIR PROCEDURE. IT WAS STATED THAT THE PATIENT IS STILL RECOVERING.

  Patient problems: Seroma

  MAUDE report 8702182 ↗
• InjuryMay 9, 2019Adverse 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 CLINICAL STUDY, 2 DAYS AFTER A PRIMARY VENTRAL HERNIA PROCEDURE, THE PATIENT WAS CONCERNED ABOUT CONSTIPATION. AN X-RAY WAS PERFORMED, WHICH CONFIRMED THE CONSTIPATION. ADDITIONAL MEDICATION WAS GIVEN FOR TREATMENT AND THE PATIENT ALSO HAD DIETARY MANAGEMENT EDUCATION, GUIDANCE, AND COUNSELING. THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE BUT CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Constipation; Insufficient Information; Radiation Exposure, Unintended

  MAUDE report 8595812 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A PRIMARY VENTRAL (UMBILICAL) HERNIA REPAIR, THE PATIENT HAD SKIN DEHISCENCE AT THE TROCAR INCISION SITE IN THE LEFT LOWER QUADRANT, THE PATIENT COMPLAINED OF BLEEDING OF NOT MORE THAN 500CC FROM THE SITE WITH PAIN AND SWELLING. THE WOUND WAS CLEAN, DRY, AND FREE OF EXUDATE. EDGES WERE WELL APPROXIMATED. THERE WAS NO INFECTION. THE PATIENT HAD A CT SCAN POST-OPERATIVELY ON AND IT WAS NORMAL. TO TREAT THE SKIN DEHISCENCE, WOUND CLOSURE STRIPS WERE APPLIED TO THE AREA.

  Patient problems: Abdominal Pain; No Code Available; Radiation Exposure, Unintended; Swelling; Wound Dehiscence

  MAUDE report 8595143 ↗
• InjuryMar 28, 2019Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST LAPAROSCOPIC VENTRAL HERNIA, THE PATIENT COMPLAINED OF RIGHT SIDED ABDOMINAL PAIN DESCRIBED AS INTERMITTENT SHARP AND STABBING PAIN THAT RADIATED TO BACK, WITH ASSOCIATED NAUSEA, VOMITING AND INABILITY TO URINATE. THE PATIENT HAD A CT SCAN OF THE ABDOMEN AS A DIAGNOSTIC TEST. THE RESULTS SHOWED A 0.3CM OBSTRUCTING STONE AT THE RIGHT URETEROVESICAL JUNCTION WITH MILD. MEDICATION GIVEN INCLUDED: FLOMAX, NORCO, AND ZOFRAN. THE PATIENT WAS ALSO HYDRATED WITH 2 LITERS OF INTRAVENOUS FLUID AND THE SUBJECT WAS REFERRED TO UROLOGY. SOME SYMPTOMS MAY BE RELATED TO POST-OPERATIVE SIDE-EFFECTS AFTER HERNIA REPAIR PROCEDURE, THOUGH RENAL STONE MAY BE UNRELATED. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Abdominal Pain; Nausea; No Code Available; Radiation Exposure, Unintended

  MAUDE report 8459890 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE PATIENT EXPERIENCED A REFRACTORY NAUSEA. THE PATIENT WAS TO BE DISCHARGED AT THE SAME DAY OF THE PROCEDURE, BUT STAYED OVERNIGHT UNTIL THE ISSUE WAS CONTROLLED. THE PATIENT WAS GIVEN MEDICATIONS AND IT WAS REPORTED THAT NAUSEA WAS LIKELY INDUCED BY THE OPERATION. THE PATIENT RECOVERED.

  Patient problems: Nausea; No Code Available

  MAUDE report 8428182 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD A SMALL SEROMA WHICH DID NOT REQUIRE TREATMENT.

  Patient problems: Seroma

  MAUDE report 8293152 ↗
• MalfunctionJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCING A BURNING SENSATION IN THE AREA OF THE HERNIA WHEN EATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209614 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: POST VENTRAL HERNIA REPAIR, THE PATIENT HAD ADYNAMIC ILEUS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2018 WITH SYMPTOMS OF NAUSEA, VOMITING, AND ABDOMINAL PAIN. MEDICATIONS WERE GIVEN. A NASOGASTRIC TUBE (NGT) WAS PLACED FOR DECOMPRESSION AND THE PATIENT WAS ORDERED NOTHING BY MOUTH. THE NGT WAS REMOVED AFTER THE PATIENT DEMONSTRATED HIGH GASTRIC OUTPUT. THE PATIENT WAS PUT ON A CLEAR LIQUID DIET. THE PATIENT TOLERATED THE DIET WELL, ADVANCED TO A REGULAR DIET, AND WAS DISCHARGED WITH COMPLETE BOWEL FUNCTION.

  Patient problems: Abdominal Pain; Nausea; No Code Available; Vomiting

  MAUDE report 7931147 ↗