Parietex TCM1510X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521178861), received between Apr 6, 2018 and Jul 28, 2023 — classified as 38 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 17415813 ↗
• InjuryJun 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, INFLAMMATION, NERVE DAMAGE, SCAR TISSUE, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17052670 ↗
• InjurySep 24, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESION, INFLAMMATION, BOWEL PROBLEMS, INFECTIONS, DEFECTIVE DEVICE, MESH FAILURE, SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, DISCOMFORT, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND MESH REVISION.

  Patient problems: Abdominal Distention; Adhesion(s); Constipation; Discomfort; Distress; Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Neuropathy; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 15477416 ↗
• 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED A MESH DESIGN DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 11807067 ↗
• InjuryNov 18, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, EMOTION DISTRESS, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, MARCY RING PLASTY, AND MESH REVISION SURGERY.

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

  MAUDE report 10860518 ↗
• InjuryNov 2, 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 RIGHT DIRECT AND RIGHT FEMORAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, BULGING, BOWEL ISSUES, KELOID SCARRING, PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE, LOSS OF COMFORT, AND DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF KELOID SCAR, AND TRIGGER POINT KENALOG INJECTION.

  Patient problems: Abdominal Distention; Abdominal Pain; Disability; Discomfort; Distress; Emotional Changes; Injury; Pain; Scar Tissue; Scarring; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 10774875 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING THE MESH IMPLANT, THE PATIENT HAD EXPERIENCED PAIN, INFLAMMATION, AND BILATERAL HYDROCELE.

  Patient problems: Inflammation; Pain

  MAUDE report 10507138 ↗
• InjuryJul 7, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN AND BULGING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Distress; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 10240283 ↗
• InjuryJul 6, 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 10232545 ↗
• InjuryMay 19, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE OF HERNIA, SPERMATIC CORD WAS ADHERENT TO THE OLD MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED DISSECTION AND REMOVAL OF SPERMATIC CORD AND REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury; Scarring

  MAUDE report 10072145 ↗
• InjuryApr 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, DIASTASIS, SEPARATION OF THE RECTUS MUSCLES, BULGE, LAXITY IN UPPER-ABDOMEN, AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, RESECTION OF HERNIA, AND LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Injury; Muscle Weakness/Atrophy; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 9996180 ↗
• InjuryApr 23, 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 THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH FLIPPED AND ATTACHED TO PERITONEUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH WAS CUT AWAY FORM PERITONEUM, AND NEW MESH WAS PLACED.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9991426 ↗
• InjuryApr 21, 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 THERAPEUTIC TREATMENT OF BILATERAL INGUINAL HERNIAS AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MESH FLIPPED AND ATTACHED TO PERITONEUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH WAS CUT AWAY FORM PERITONEUM, AND NEW MESH WAS PLACED.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9982714 ↗
• InjuryFeb 28, 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. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, VOMITING, ABDOMINAL PAIN, OBSTRUCTION, AND ADHESIONS.POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF DENSE ADHESIONS, RELEASE OF SMALL BOWEL OBSTRUCTION, RECURRENT VENTRAL HERNIA REPAIR WITH NEW MESH AND REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Injury; Obstruction/Occlusion; Pain; Vomiting

  MAUDE report 9770770 ↗
• InjuryFeb 20, 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 RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LEFT INGUINAL HERNIA REPAIR WITH MESH, PANTALOON HERNIA AND RIGHT INGUINAL RECURRENT HERNIA REPAIR, AND ROBOTIC ASSISTED LAPAROSCOPIC REPAIR OF LEFT INGUINAL HERNIA AND FEMORAL HERNIA, LYSIS OF ADHESIONS, AND RIGHT RECURRENT INGUINAL HERNIA REPAIR WITH PROGRIP MESH.

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

  MAUDE report 9731357 ↗
• InjuryNov 21, 2019Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, EITHER THE MESH OR TACKS USED HAD TORN THE SURROUNDING ORGANS OR TISSUES. THE NET SHRANK AND CAUSED BLEEDING. THE PATIENT HAD CHRONIC PAIN IN THE GROIN, AND A CHRONIC PAINFUL CONSTIPATION.

  Patient problems: Constipation; Pain; Tissue Damage

  MAUDE report 9357284 ↗
• InjuryNov 20, 2019Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, BULGING, MESH MIGRATION, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REPAIR OF RECURRENT HERNIA.

  Patient problems: Abdominal Distention; Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 9346022 ↗
• InjuryJul 25, 2019Mechanics 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 RECURRENCE, EXTENSIVE SCARRING, PAIN, NODULE, NAUSEA, MESH ADHERENT TO NERVE, LOSS OF APPETITE, NERVE DAMAGE, ADHESIONS, GRANULOMA, SPERMATIC CORD INVOLVED AND LEFT GROIN TRIGGER POINT PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL. THE PATIENT HAS ONGOING MEDICAL ISSUES INCLUDING THE NEED FOR FUTURE MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Emotional Changes; Granuloma; Hernia; Inflammation; Injury; Nausea; Nerve Damage; No Code Available; Nodule; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 8828418 ↗
• InjuryJul 25, 2019Loss of or Failure to Bond; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 RECURRENT HERNIA DUE TO FAILURE OF THE MESH, FAILURE TO INCORPORATE, PAIN, BURNING SENSATION, SWELLING OF RIGHT GROIN, HYDROCELE, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, REVISION, REPAIR OF HERNIA WITH PERFIX PLUG AND BARD MESH, RIGHT ILIOGUINAL/ILIGOHYPOGASTRIC NERVE INJECTION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Emotional Changes; Failure of Implant; Hernia; Injury; No Code Available; Pain; Scar Tissue; Scarring; Swelling; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8828232 ↗
• InjuryJul 15, 2019Migration 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 A RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DIAGNOSTIC LAPAROSCOPY AND MESH FOLDED OVER. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 8791782 ↗
• InjuryJul 11, 2019Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Integrity 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 AN ADVERSE OUTCOME.

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

  MAUDE report 8783031 ↗
• InjuryJul 10, 2019Mechanics 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 SEVERE PAIN, NAUSEA, INFLAMMATION, LOSS OF APPETITE, NERVE DAMAGE, ADHESIONS, MENTAL ANGUISH/PAIN, EMOTIONAL DISTRESS, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH EXPLANT, MESH INTERVENTION SURGERY, AND ADDITIONAL IMPLANT. THE PATIENT HAS ONGOING MEDICAL ISSUES INCLUDING THE NEED FOR FUTURE MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Distress; Emotional Changes; Hernia; Inflammation; Injury; Nausea; Nerve Damage; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 8776394 ↗
• InjuryJul 5, 2019Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SCARRING, MESH FAILURE, INFLAMMATION, INFECTION, PAIN, REDNESS, DRAINAGE TO THE MOST SUPERIOR PORTION OF THE INCISION, STITCH ABSCESS AND PUS WITH POLYPROPYLENE STITCH AT ITS BASE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Discharge; Erythema; Fluid Discharge; Hernia; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8765016 ↗
• InjuryJul 5, 2019Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SCARRING, MESH FAILURE, INFLAMMATION, INFECTION, PAIN, REDNESS, DRAINAGE TO THE MOST SUPERIOR PORTION OF THE INCISION, STITCH ABSCESS AND PUS WITH POLYPROPYLENE STITCH AT ITS BASE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Discharge; Erythema; Fluid Discharge; Hernia; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8765005 ↗
• InjuryJul 3, 2019Migration 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SCAR TISSUE, AND MESH HAD PULLED AWAY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND RECURRENT VENTRAL HERNIA REPAIR WITH MESH.

  Patient problems: Hernia; Injury; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 8761461 ↗