Parietene PPM1508X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521213814), received between Aug 27, 2017 and Apr 7, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (9 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 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 PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24801789 ↗
• InjuryMar 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 PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24520765 ↗
• InjuryDec 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ILIOINGUINAL BLOCK, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH AND MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23821848 ↗
• InjuryNov 24, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23638844 ↗
• InjuryNov 3, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Hernia; Unspecified Tissue Injury

  MAUDE report 23457715 ↗
• InjuryJul 31, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY.

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

  MAUDE report 22681935 ↗
• 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, AND MEDICATION.

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

  MAUDE report 22301086 ↗
• InjuryJan 5, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, NECROSIS, SMALL FASCIAL NODULE, NODULE/POSSIBLE NEUROMA, FOCAL FIBROUS SCARRING, MESH EVENTRATION, PINCHING SENSATION, NERVES FLARE UP TINGLE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL EXPLANT SURGERY, REVISION SURGERY, REMOVAL SURGERY, REMOVAL RETAINED SUTURE, ABDOMINAL WALL RECONSTRUCTION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fibrosis; Hernia; Inflammation; Necrosis; Nodule; Pain; Paresthesia; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 18461023 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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, INFLAMMATION, ADHESIONS, OBSTRUCTION, URINARY INCONTINENCE, CONSTIPATION, DIARRHEA, SWELLING, DISCOMFORT, AND MESH RIPPED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MEDICATION.

  Patient problems: Adhesion(s); Constipation; Diarrhea; Discomfort; Hernia; Inflammation; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 18141878 ↗
• InjuryOct 18, 2021Mechanics 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, CHRONIC AND SEVERE PAIN, NERVE PAIN, ADHESIONS, SCAR TISSUE, MENTAL PAIN/ANGUISH, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, EMOTIONAL DISTRESS, AND EXTENSIVE SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 12646843 ↗
• InjurySep 2, 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 LEFT GROIN HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFLAMMATION, OBSTRUCTION, PAINFUL URINATION, HERNIA RECURRENCE, LEFT INGUINAL CANAL LATERAL WALL WEAKNESS, BULGING, BOWEL COMPLICATIONS/ISSUES, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND REVISION SURGERY.

  Patient problems: Abdominal Distention; Discomfort; Dysuria; Fistula; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 12418293 ↗
• InjuryAug 5, 2021Mechanics 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, ERYTHEMA, ABSCESS, INFECTION, REACTIVE FLUID, OPEN WOUND, AND PURULENT DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF ABSCESS, SCROTAL EXPRESSING/WASHOUT/DEBRIDEMENT, WOUNDS PACKED, AND ADMISSION TO HOSPITAL.

  Patient problems: Abdominal Pain; Abscess; Constipation; Decreased Appetite; Emotional Changes; Erythema; Fluid Discharge; Impaired Healing; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12285102 ↗
• InjuryJul 2, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH ENTRAPPED IN SPERMATIC CORD/ GENITAL NERVE/ ILIOHYPOGASTRIC NERVE, AND PAIN/ SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, REVISION SURGERY, AND LIGATION OF NERVES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Tissue Injury

  MAUDE report 12112236 ↗
• InjuryMay 11, 2021Mechanics 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 IMPLANT, THE PATIENT EXPERIENCED DESIGN DEFECT, PAIN, DISFIGUREMENT, INFECTION, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESION, OBSTRUCTIONS, AND BLEEDING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11807433 ↗
• InjuryMay 7, 2021Mechanics 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 11794619 ↗
• InjuryApr 8, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, NERVE ENTRAPMENT, RECURRENCE, AND NERVE PAIN RADIATING TO FOOT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11636231 ↗
• InjuryApr 8, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, NERVE ENTRAPMENT, RECURRENCE, AND NERVE PAIN RADIATING TO FOOT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, NERVE BIOPSY OF RIGHT ILIOINGUINAL NERVE, SOFT TISSUE DEBRIDEMENT, AND MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11634597 ↗
• InjuryFeb 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SCARRING, NERVE ENTRAPMENT, DISCOMFORT, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NEUROLYSIS, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11385014 ↗
• 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 INFECTION AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Atrial Fibrillation; Cellulitis; Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Low White Blood Cell Count; Necrosis; Obstruction/Occlusion; Pain; Purulent Discharge; Respiratory Insufficiency; Scar Tissue; Sepsis; Swelling/ Edema; Tachycardia; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 11078468 ↗
• InjuryDec 22, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, IMPAIRMENT, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, MESH FAILURE, RECURRENCE, SCARRING, AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Incontinence; Inflammation; Neuralgia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11057495 ↗
• InjuryDec 9, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 10978931 ↗
• InjuryDec 9, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NERVE ABLATION, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Hernia; Nerve Damage; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 10978917 ↗
• InjuryDec 9, 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 BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 10977032 ↗
• InjuryNov 24, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, STOMA RECITING, AND RELEASED ADHESIONS.

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

  MAUDE report 10898415 ↗
• InjuryNov 23, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 10886261 ↗