ProGrip TEM2015GRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10884521177734), received between Oct 20, 2017 and Jul 18, 2025 — classified as 65 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (24 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 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 A PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH DISRUPTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 22543869 ↗
• InjuryMar 31, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21732178 ↗
• InjuryMar 20, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21657465 ↗
• InjuryFeb 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21494884 ↗
• InjuryJul 2, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19658996 ↗
• InjuryJul 2, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19658805 ↗
• InjuryJul 2, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19658784 ↗
• InjuryFeb 14, 2024Mechanics 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 DISCOMFORT, DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, REVISION SURGERY, TAKE DOWN OF ADHESIONS.

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

  MAUDE report 18706995 ↗
• InjuryDec 1, 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 PARASTOMAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, BOWEL INVOLVEMENT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18247437 ↗
• InjuryMay 18, 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, RECURRENCE, PAIN, SCARRING, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16955419 ↗
• InjuryApr 27, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, PAIN, SCARRING, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 16827102 ↗
• InjuryMar 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, SWELLING, SCAR TISSUE, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16600453 ↗
• InjuryMar 9, 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, INFECTION, ABSCESS, RECURRENCE, PAIN, INFLAMMATION, NERVE DAMAGE, MENTAL PAIN, SCARRING, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Abscess; Discomfort; Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16513225 ↗
• InjuryFeb 2, 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 VENTRAL AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, PAIN, MENTAL PAIN, RECURRENCE, ABDOMINAL PAIN, DISCOMFORT, BLOATING, ADHESIONS, INFLAMMATION, MESH FAILED, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REMOVED A PORTION OF MESH, MEDICATION, AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16287707 ↗
• InjuryDec 12, 2022Adverse 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 PAIN, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH EXPLANTATION.

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

  MAUDE report 15965075 ↗
• InjuryDec 9, 2022Adverse 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 PAIN IN LOWER ABDOMEN, CANNOT LIFT HEAVY ITEMS WITHOUT PAIN, INCARCERATION OF HERNIA, INFLAMMATION, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, AND OMENTECTOMY.

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

  MAUDE report 15953168 ↗
• InjuryNov 21, 2022Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, ADHESIONS, RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15839907 ↗
• InjuryNov 17, 2022Adverse 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 THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, HERNIA RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTIONS, SEROMA, DRAINAGE, MESH ENCAPSULATION, SCARIFICATION, AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HOSPITALIZATION, LYSIS OF ADHESIONS, EXPLORATION OF ABDOMEN, MESH REMOVAL, LAPAROSCOPIC, BOWEL RESECTION, AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Dehydration; Discomfort; Electrolyte Imbalance; Fluid Discharge; Foreign Body Reaction; Hernia; Hypoxia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15820475 ↗
• InjuryOct 3, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, RECURRENCE, ADHESIONS, DISCOMFORT, MENTAL PAIN, DISABILITY, INFLAMMATION, EMOTIONAL DISTRESS, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC/ROBOTIC SURGERY FOR AN INCARCERATED RECURRENT INCISIONAL HERNIA AND BILATERAL COMPONENT SEPARATION.

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

  MAUDE report 15530551 ↗
• InjuryMay 3, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 14269834 ↗
• InjuryApr 5, 2022Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, SCARRING, IMPAIRMENT, MENTAL PAIN, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, MESH MIGRATION, FAILURE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

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

  MAUDE report 14014690 ↗
• InjuryDec 7, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; 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 FAILURE OF MESH, MESH MIGRATION, MESH PROTRUDING THROUGH SKIN, ABDOMINAL PAIN, PAIN, CHRONIC INFLAMMATION, BOWEL NECROSIS, FISTULA, EXTENSIVE BOWEL ADHESION, BOWEL DESEROSALIZATION, BOWEL EROSION, ENTEROTOMY, DEFECTIVE MESH, MENTAL PAIN, DISABILITY, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED CORRECTIVE MEDICAL CARE, BOWEL RESECTION, AND REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Fistula; Hernia; Inflammation; Necrosis; Nodule; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 12954813 ↗
• InjurySep 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE,DEFECTIVE MESH, HERNIA RECURRENCE, ADHESIONS, NECROSIS, INFLAMMATION, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Necrosis; Pain; Scar Tissue; Skin Erosion; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12431416 ↗
• InjuryAug 1, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED SEROMA FLUID DRAINAGE, ADHESIONS, SCAR TISSUE, RECURRENCE, ABSCESS, FLUID COLLECTION, PEPTONIPHILUS ASACCHAROLYTICUS GRAM +, CLOUDY YELLOW/ORANGE-COLORED FLUID, PAIN, DEHISCENCE OF MIDLINE INCISION, AND OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE/REMOVAL OF CATHETER, HERNIA REPAIR WITH NEW MESH, REMOVAL OF MESH, LYSIS OF ADHESIONS, DRAINAGE OF SEROMA, WOUND VAC, ASPIRATION, BILATERAL TRANSVERSUS ABDOMINIS MUSCLE RELEASE RECTUS ABDOMINIS MUSCLE ADVANCEMENT FLAPS, RESECTION OF REDUNDANT DEFORMED SKIN/SCAR, ABDOMINAL WALL WITH SKIN FLAP CLOSURE, ABDOMINAL PANNICULECTOMY, SEROMA CAVITY WAS PACKED, EXCISION OF ABDOMINAL SKIN SCAR AND WOUND SEROMA CAVITY WITH ADJACENT ISSUE REARRANGEMENT, AND REMOVAL OF SCAR TISSUE.

  Patient problems: Abscess; Adhesion(s); Ascites; Bacterial Infection; Fluid Discharge; Hernia; Impaired Healing; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12257287 ↗
• InjuryJul 2, 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LIPOMA OF THE CORD, RECURRENT HERNIA, THICKENED SPERMATIC CORD, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 12109253 ↗