Parietene PPM1106X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521213807), received between Jun 11, 2019 and Jun 9, 2026 — classified as 10 injuries.

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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 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 EMOTIONAL DISTRESS, PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, AND HERNIA REPAIR WITH MESH.

  Patient problems: Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25446143 ↗
• 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 RECURRENCE, PAIN.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 24802013 ↗
• InjuryMar 4, 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 UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24512505 ↗
• InjuryMay 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 A LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, RECURRENCE, INFLAMMATION, SCARIFICATION, PAIN, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, AND SURGERY TO CORRECT DEVICE.

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

  MAUDE report 16903168 ↗
• InjuryJun 25, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, NERVE ENTRAPMENT, NERVE DAMAGE, ADHESIONS, MESHOMA, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, MESH INTERVENTION SURGERY AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Neuralgia; Neuropathy; Nodule; Numbness; Pain; Scar Tissue; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 12067645 ↗
• InjuryJun 25, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, NERVE ENTRAPMENT, NERVE DAMAGE, ADHESIONS, MESHOMA, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, MESH INTERVENTION SURGERY AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Constipation; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Nerve Damage; Neuralgia; Neuropathy; Nodule; Numbness; Pain; Scar Tissue; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 12067471 ↗
• InjuryMar 26, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, LYMPHOID HYPERPLASIA, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, EXCISED LYMPH NODE, AND REMOVAL OF MESH.

  Patient problems: Hyperplasia; Injury; Nerve Damage; Pain

  MAUDE report 9884045 ↗
• InjuryMar 26, 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 LEFT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, CORD STRUCTURES WERE ENTRAPPED IN SCAR TISSUE, PAIN, LYMPHOID HYPERPLASIA, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, EXCISED LYMPH NODE, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Hernia; Hyperplasia; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 9884029 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 LAPAROSCOPIC CONVERTED TO OPEN THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE ABSCESS, FISTULA, BOWEL STUCK TOGETHER, PERFORATED VISCUS, BOWEL INFLAMED, AND LARGE AMOUNT OF PUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, REMOVAL OF MESH, AND WOUND VAC.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Depression; Discomfort; Distress; Emotional Changes; Fistula; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9565004 ↗
• InjuryJun 11, 2019Adverse 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 RECURRENCE, ADHESIONS AND MESH DISRUPTED BY PULLING OUT OF ITS SUTURES.

  Patient problems: Injury

  MAUDE report 8686891 ↗