Permacol P101010Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884523000108), received between Sep 21, 2017 and Sep 30, 2022 — classified as 35 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• InjurySep 30, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, NAUSEA, VOMITING, INFECTION, AND ABDOMINAL HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, INCISION AND DEBRIDEMENT OF ABDOMINAL WALL, HERNIA REPAIR WITH VENTRALEX MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Chills; Cough; Discomfort; Fever; Foreign Body Reaction; Hernia; Impaired Healing; Nausea; Nodule; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15515307 ↗
• InjuryOct 18, 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 PAIN, HERNIA RECURRENCE, BULGE, PARTIAL OBSTRUCTIVE SYMPTOMS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RIGHT/LEFT MYOFASCIAL ADVANCEMENT FLAP, TRANSVERSE ABDOMINIS BLOCK WITH BUPIVICAINE, REMOVAL OF MESH, SUTURES/TACKS REMOVED, HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS, AND ON-Q PAIN CATHETER/PUMP PLACEMENT.

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

  MAUDE report 12647618 ↗
• InjuryMay 18, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, PAIN, WOUND DEHISCENCE, PUS, PELVIC ABSCESS, GIANT CELL REACTION, OBSTRUCTIONS, BLEEDING, SEROMA, REDUCED MOBILITY, PURULENT FLUID, RECURRENCE, ADHESIONS, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, INCISION AND DRAINAGE, DEBRIDEMENT, COLOSTOMY REVISION, PARASTOMAL HERNIA REPAIR, LYSIS OF ADHESIONS, REVISION SURGERY, HERNIA REPAIR WITH MESH, AND REMOVAL OF MESH.

  Patient problems: Abscess; Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Fever; Fistula; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention; Wound Dehiscence

  MAUDE report 11846162 ↗
• InjuryMay 6, 2021Adverse 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 VENTRAL HERNIAS. IT WAS REPORTED THAT AFTER THE ONLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, SEROMA, INFECTION, PAIN, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE MESH REMOVAL SURGERIES AND REMOVAL OF SEROMA.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Nodule; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11787603 ↗
• InjuryApr 23, 2021Migration 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 ADHESIONS, RECURRENCE, CHRONIC DRAINING WOUND, FIBRINOUS DEBRIS, SINUS TUNNEL, RECTUS DIASTASIS, MESH ROLLED UP ON ONE OF EDGES, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND DEBRIDEMENT WITH PRIMARY CLOSURE, HERNIA REPAIR WITH NEW MESH, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, AND MESH REMOVAL.

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

  MAUDE report 11715887 ↗
• InjuryDec 12, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SCARRING, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RECURRENCE REPAIR, ANTERIOR LAPAROSCOPIC GASTROPEXY, HOLE IN STOMACH MADE DURING DISSECTION CLOSED, AND UPPER ENDOSCOPY.

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

  MAUDE report 10995808 ↗
• InjuryDec 8, 2020Migration or Expulsion of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEPARATION OF MATERIAL LAYERS, ADHESIONS, FISTULA, RECURRENCE, ABSCESS, FIBROADIPOSE TISSUE, GRANULATION TISSUE, FOREIGN BODY REACTION, INFLAMMATION, HEMORRHAGE, HISTIOCYTIC REACTION, PAIN, BULGE, LOOSE MESH, LACK OF INCORPORATION, DRAINAGE, SINUS TRACT, PURULENT MATERIAL, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF SUTURE MATERIAL, HERNIA REPAIR WITH NEW MESH, EXCISION OF INFECTED FOREIGN BODY (CONTAMINATED PROSTHETIC MESH) <(>&<)> MEDICATION.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10970262 ↗
• InjuryDec 1, 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 ADHESIONS AND SEVERE PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH EXPLANT.

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

  MAUDE report 10929808 ↗
• InjuryJul 14, 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 AN INCISIONAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH DEFORMATION, MESH MIGRATION, ABDOMINAL PAIN, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, TRANSABDOMINAL PREPERITONEAL BLOCK, HERNIA SACS REMOVED, AND MESH REMOVAL.

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

  MAUDE report 10271796 ↗
• InjuryJul 13, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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, POOR TISSUE INTEGRITY, ADHESIONS, SCAR TISSUE, AND ATROPHY OF THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND LYSIS OF ADHESIONS.

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

  MAUDE report 10265051 ↗
• InjuryMar 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH "FOLDED OVER THE ANTERIOR ESOPHAGUS," MESH MIGRATION AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED TWO REMOVAL SURGERIES.

  Patient problems: Injury; Scarring

  MAUDE report 9800102 ↗
• InjuryMar 6, 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 IMPLANT, THE PATIENT EXPERIENCED INFECTION AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 9799951 ↗
• InjuryMar 4, 2020Adverse 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, HEMATOMA, BLEEDING, ADHESIONS, MESH TORN, AND DISCHARGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR, AND WOUND VAC.

  Patient problems: Adhesion(s); Blood Loss; Discharge; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9784913 ↗
• InjuryJan 21, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH FAILURE, ADHESIONS, RECURRENCE, BULGING, FIBROTIC TISSUE, ECTOPIC CALCIFICATION ALONG SCAR, WEAK MESH, LACK OF INCORPORATION, PANCREATITIS, RENAL FAILURE, INFLAMMATION, AND BOWEL OBSTRUCTION. POST-IMPLANT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, CHOLECYSTECTOMY, CHOLANGIOGRAM, AND BILATERAL COMPONENT SEPARATION.

  Patient problems: Abdominal Distention; Adhesion(s); Calcium Deposits/Calcification; Failure of Implant; Fibrosis; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Renal Failure

  MAUDE report 9610274 ↗
• InjuryOct 3, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, AND DENSE ADHESIONS OF THE SMALL BOWEL TO THE PRIOR PIECE OF MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPAIR OF RECURRENT INCISIONAL HERNIA WITH NEW BARD PHASIX MESH AND OTHER MESHES ON LATER DATES, EXCISION OF PRIOR MESH AND LYSIS OF ADHESIONS.

  Patient problems: Abscess; Adhesion(s); Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Pain; Scar Tissue; Scarring; Unspecified Tissue Injury

  MAUDE report 9152937 ↗
• InjurySep 30, 2019Loss of or Failure to Bond; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 LAPAROSCOPIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTED AND PULLED AWAY FROM THE FASCIAL EDGE, EXTENSIVE ADHESIONS, AND SMALL SEROSAL TEAR/ENTEROTOMY REPAIRED WITH SUTURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. THE DEVICE HAD BEEN USED WITH ENDOTAK.

  Patient problems: Adhesion(s); Injury

  MAUDE report 9136740 ↗
• InjurySep 11, 2019Material 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 VENTRAL INCISIONAL HERNIA AND PARTIAL SMALL BOWEL OBSTRUCTION. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DENSE ADHESIONS, CONTRACTED MESH, GRANULOMA, SEVERE PAIN, CHRONIC WOUND, SCARRING, DISFIGUREMENT, DRAINAGE, ABDOMINAL PAIN, JEJUNAL POLYP, BULGING KNOT OF TISSUE/SUTURE/AND RETAINED MESH, SEROSAL INJURY, AND PERITONEAL FOREIGN BODY. POST-OPERATIVE PATIENT TREATMENT INCLUDED SKIN DEBRIDEMENT, REMOVAL, AND EXCISION OF FOREIGN BODY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Discharge; Foreign Body In Patient; Granuloma; Hernia; Impaired Healing; Injury; No Code Available; Pain; Scar Tissue; Scarring

  MAUDE report 8986951 ↗
• InjuryAug 22, 2019Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, MESH FOLDED UP, ADHESIONS, AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISIONS, REMOVAL OF MESH, REPAIR OF HERNIA WITH PARIETEX MESH, SMALL BOWEL ENTEROTOMY REPAIR, AND LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Erosion; Hernia; Injury; Pain

  MAUDE report 8923728 ↗
• InjuryJul 31, 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 PELVIC RELAXATION AND LARGE RECTOCELE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS, INCONTINENCE, DYSPAREUNIA, CYSTOCELE, PROLAPSE, VAGINA HAS DROPPED FURTHER, PELVIC FLOOR DYSFUNCTION, RIGHT FLANK PAIN, WATERY DIARRHEA, URINARY RETENTION, DECREASED LIBIDO, MENOPAUSAL SYMPTOMS, VAGINAL DISCOMFORT, VAGINAL BLEEDING AND VAGINAL ATROPHY. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Blood Loss; Diarrhea; Discomfort; Incontinence; Injury; No Code Available; Pain; Prolapse; Urinary Retention; Urinary Tract Infection

  MAUDE report 8848616 ↗
• InjuryJul 10, 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 INFECTED UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, CHRONIC DRAINING WOUND, PUS, AND SEROSAL TEARS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH DUE TO INFECTION, DISSECTION AND DRAINAGE OF SINUS TRACT ABSCESS, LYSIS OF DENSE ADHESIONS, REPAIR OF SEROSAL TEARS AS WELL AS WOUND EXPLORATION AND WASHOUT. THE DEVICE WAS USED WITH AN UNKNOWN LAPAROSCOPIC TACKER.

  Patient problems: Abscess; Adhesion(s); Discharge; Excessive Tear Production; Impaired Healing; Injury; Purulent Discharge; Unspecified Infection

  MAUDE report 8777222 ↗
• InjuryJul 3, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN OPEN WOUND AND INFECTION.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Discomfort; Edema; Erythema; Fever; Fluid Discharge; Impaired Healing; Inflammation; Injury; No Code Available; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8761525 ↗
• InjuryJul 3, 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 TWO INCISIONAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED RECURRENT INCISIONAL HERNIA REPAIRS.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8756572 ↗
• InjuryJun 28, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, OPEN WOUND, DRAINING SEROMA WITH EXPOSED MESH, PARTIAL MESH UNINCORPORATED WITH FIBRINOUS EXUDATE, RECURRENCE, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, REMOVAL OF MESH, AND REVISION SURGERY.

  Patient problems: Discharge; Fluid Discharge; Hernia; Impaired Healing; Injury; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8744229 ↗
• InjuryApr 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 RECURRENT INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, EXTENSIVE ADHESIONS, ADHESED SMALL BOWEL TO EXISTING MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED A DIAGNOSTIC LAPAROSCOPY, OPEN LYSIS OF ADHESIONS, OPEN VENTRAL HERNIA REPAIR WITH PRIMARY CLOSURE OF EXISTING PARIETEX MESH, MEDICATION, MESH REMOVAL SURGERY, REMOVAL OF MULTIPLE HELICAL TACKS, PLACEMENT OF TISSIL, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 8504706 ↗
• InjuryApr 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 AN INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS (SUBCUTANEOUS SCAR TISSUE AND DISCRETE CIRCULAR LESION), PAIN, GRANULOMA, AND NIDUS FOR INFLAMMATORY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF DISCRETE CIRCULAR LESION, EXCISION OF STICH GRANULOMA, DRAINAGE OF ABSCESS, AND REMOVAL OF OLD STITCH.

  Patient problems: Abscess; Granuloma; Inflammation; Injury; No Code Available; Pain; Scar Tissue

  MAUDE report 8503985 ↗