Parietex PCO8OSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521179721), received between Mar 20, 2018 and May 3, 2023 — classified as 1 death, 23 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY MESH REMOVAL.

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

  MAUDE report 16861297 ↗
• InjuryApr 8, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND MESHOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 14059907 ↗
• InjuryOct 18, 2021Degraded; Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Degraded; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, MESH CONTRACTION, FIRM MESH, MESH MIGRATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, COMPONENT SEPARATION, FASCIOCUTANEOUS FLAP/MYOCUTANEOUS FLAP, AND REMOVAL OF OLD MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Discomfort; Emotional Changes; Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12652734 ↗
• InjuryOct 18, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, HERNIA RECURRENCE, MESH MIGRATION, SEROMA, INFECTION, SMALL BOWEL OBSTRUCTION, FLUID FILLED CAVITY WITH APPEARANCE OF PURULENCE, FIBROADIPOSE TISSUE, INFLAMMATION, FOREIGN BODY GIANT CELLS, FOAMY HISTIOCYTES, OLD SCAR, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, NG TUBE PLACED, LYSIS OF ADHESIONS, AND MESH REMOVAL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Erosion; Foreign Body Reaction; Hernia; Inflammation; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12652696 ↗
• InjuryAug 16, 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 ADHESIONS, ABDOMINAL PAIN, TENDERNESS, RECURRENCE, INFECTION, PAIN, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, RELEASE OF OMENTUM FROM ANTERIOR ABDOMINAL WALL, RECURRENT HERNIA REPAIR, DRAIN OF ABSCESS, WOUND VAC PLACEMENT, AND HERNIA REPAIR WITH MESH ADDED.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Bacteremia; Bacterial Infection; Discomfort; Erythema; Hernia; Inflammation; Nodule; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12325387 ↗
• InjuryJan 11, 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 IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 11151358 ↗
• InjuryDec 2, 2020Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; 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 AN UMBILICAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, PAIN, AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 10936119 ↗
• InjurySep 24, 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 THERAPEUTIC TREATMENT OF A MIDLINE MID ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SEVERE PAIN, RECURRENCE, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Hernia; Inflammation; Injury; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 10583741 ↗
• InjuryAug 17, 2020Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND EDGE OF PRIOR MESH WAS FOUND TO HAVE RE-HERNIATED INTO THE ABDOMINAL WALL DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10418318 ↗
• DeathApr 16, 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 LOSS OF BOWEL, RECURRENCE, PAIN, INFECTION, ABSCESS, ADHESIONS, SMALL BOWEL OBSTRUCTION, SEROMA, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Nodule; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9968981 ↗
• InjuryMar 13, 2020Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; 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 ABDOMINAL WALL ABSCESS AND INFECTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVED AND ADDITIONAL IMPLANT.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Discomfort; Distress; Electrolyte Imbalance; Emotional Changes; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Injury; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 9828458 ↗
• InjuryFeb 4, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, HERNIA RECURRENCE, OBSTRUCTION AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 9664020 ↗
• InjuryOct 2, 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 AN INCARCERATED EPIGASTRIC INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9147888 ↗
• InjuryJun 11, 2019Adverse 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 A RECURRENT INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION, DRAINING WOUND, AND ABDOMINAL WALL ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL AND MUCOID PUS DEBRIDED.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Injury; Pain; Perforation; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8688604 ↗
• InjuryFeb 19, 2019Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE AND REMOVAL. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 8351168 ↗
• InjuryJan 10, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 OMENTAL ADHESIONS AND HERNIA RECURRENCE. TREATMENT PROVIDED FOR THESE CONDITIONS INCLUDED SURGICAL REVISION IN (B)(6) 2016.

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

  MAUDE report 8232936 ↗
• InjuryAug 9, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; 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 AN INCARCERATED VENTRAL/INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE MESH TORE ALONG THE MIDLINE. THE PATIENT ALSO EXPERIENCED RECURRENCE OF BOTH HERNIAS, SMALL-BOWEL OBSTRUCTION, AND ADHESIONS. TREATMENT INCLUDED SURGICAL LYSIS OF ADHESIONS, REVISION OF THE MESH, AND LATER A FULL REMOVAL OF THE MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cough; Disability; Failure of Implant; Fibrosis; Fistula; Fluid Discharge; Hematuria; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Pulmonary Embolism; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7770843 ↗
• InjuryAug 8, 2018Adverse 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 A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED HERNIA RECURRENCE, PAIN, MESH REMOVAL.

  Patient problems: Adhesion(s); Hernia; Injury; No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 7762972 ↗
• InjuryJul 19, 2018Patient-Device Incompatibility; Adverse 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 A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. AFTER TREATMENT, THE PATIENT EXPERIENCED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Complaint, Ill-Defined; Hernia; Incontinence; Injury; No Code Available; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 7703898 ↗
• InjuryJul 17, 2018Defective Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; Material Integrity 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE WRINKLED CONTRACTED MESH, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, REMOVAL OF PRIOR MESH AND RECURRENT INCISIONAL HERNIA REPAIR WITH PLACEMENT OF NEW MESH.

  Patient problems: Adhesion(s); Erosion; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; No Code Available; Pain; Unspecified Tissue Injury; Vomiting; Weight Changes

  MAUDE report 7694672 ↗
• InjuryMay 15, 2018Adverse 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. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED RECURRENCE AND REVISION. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING REVISION SURGERY.

  Patient problems: Adhesion(s); Hematoma; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 7514175 ↗
• InjuryApr 24, 2018Migration 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS INCISIONAL HERNIA. THE PROCEDURE PERFORMED WAS INCISIONAL HERNIA REPAIR WITH MESH. ON (B)(6) 2016 - THE PATIENT UNDERWENT A SURGICAL REVISION FOR LAPAROSCOPY, THEN OPEN SIGMOID COLECTOMY AND REPAIR OF INCISIONAL HERNIA WITH THE PRE-OP AND POST-OP DIAGNOSIS WAS DIVERTICULITIS AND PROBABLE DIVERTICULAR ABSCESS, ALSO INCISIONAL HERNIA.THE PATIENT EXPERIENCED MESH HAD MIGRATED INTO THE HERNIA SAC, CHRONIC PAIN, AND RE-HERNIATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7457115 ↗
• InjuryApr 10, 2018Adverse 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS VENTRAL INCISIONAL HERNIA THE PROCEDURE PERFORMED WAS VENTRAL INCISIONAL HERNIA REPAIR. THE PATIENT EXPERIENCED DAMAGES INCLUDE BUT ARE NOT LIMITED TO REVISION/REMOVAL.

  Patient problems: Distress; Injury; No Code Available; Unspecified Tissue Injury

  MAUDE report 7412684 ↗
• InjuryMar 20, 2018Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A HERNIA REPAIR. THE PATIENT HAD REVISION SURGERY 1 YEAR POST-SURGERY. HE ALSO HAD SURGERY ON (B)(6) 2013. THE PATIENT EXPERIENCED INFECTED MESH, REVISION SURGERY, AND PAIN.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 7352643 ↗