Permacol P101828Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884523000139), received between Apr 20, 2018 and Mar 8, 2024 — classified as 27 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, TROUBLE USING THE RESTROOM, ATTENUATED <(>&<)> THIN EPIGASTRIC FASCIA, <(>&<)> SEROSAL TEARS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, BILATERAL MYOCUTANEOUS ADVANCEMENT FLAPS FOR COMPONENTS SEPARATION, ADJACENT TISSUE TRANSFER OF ABDOMINAL WALL SKIN, MEDICATION, PARTIAL REMOVAL OF MESH, REPAIR OF SEROSAL TEARS, <(>&<)> LYSIS OF ADHESIONS.

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

  MAUDE report 18870702 ↗
• InjuryJan 16, 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 AN INCARCERATED HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE ADHESIONS, RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDES HERNIA REPAIR WITH NEW MESH AND MEDICATION.

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

  MAUDE report 18518871 ↗
• InjurySep 9, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

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

  MAUDE report 12448591 ↗
• InjuryJul 2, 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 RIGHT ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS TO SMALL INTESTINE, INFECTION, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, AND REVISION SURGERY.

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

  MAUDE report 12110293 ↗
• InjuryMay 20, 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 INFLAMMATION, OBSTRUCTION, OPEN WOUND, CELLULITIS, DRAINAGE, GR ANULOMATOUS FIBRINOUS EXUDATE, INFECTION, ADHESIONS, LOSS OF DOMAIN, LEUKOCYTOSIS, ABDOMINAL PAIN, TENDERNESS, SCAR TISSUE, ELEVATED LACTATE LEVEL, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, REVISION SURGERY, LYSIS OF AD HESIONS, ADMISSION TO HOSPITAL, DRAIN PLACEMENT, ICU, MEDICATION, AND WOUND VAC PLACEMENT. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2011: OP NOTE STATED LEUKOCYTOSIS AND ELEVATED LACTATE LEVEL.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Discomfort; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11855448 ↗
• InjuryMay 14, 2021Migration 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DETACHMENT, MESH SEPARATION, HERNIA RECURRENCE, MESH RUPTURED IN MIDDLE CREATING HERNIA DEFECT, MESH RETRACTED LATERALLY TO BOTH SIDES, NEOVASCULAR ATTACHMENTS TO THE MESH, ADHESIONS, OPEN DRAINING WOUND, HEMATOMA, AND CHRONIC ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND REMNANTS OF MESH WERE REMOVED.

  Patient problems: Adhesion(s); Fluid Discharge; Hematoma; Hernia; Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 11829000 ↗
• InjuryMay 14, 2021Degraded; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Migration or Expulsion of Device; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED VENTRAL HERNIA RECURRENCE, INCARCERATED HERNIA, MESH STRETCHED OUT/SPLAYED, MESH MIGRATION, FOLDED MESH, ADHESIONS, SMALL BOWEL OBSTRUCTION, FISTULA, INFECTION, ABSCESS, DRAINAGE, DRAINING SINUS TRACT, NAUSEA, VOMITING, ABDOMINAL PAIN, FLUID COLLECTION, FOREIGN BODY GIANT CELL REACTION, ABDOMINAL PAIN, SEROMA, FEVER, INFLAMMATION, BLOATING, CRAMPING, DRY HEAVES, CHILLS, DIARRHEA, LOSS OF APPETITE, RASH, DISTENDED SMALL BOWEL LOOPS, EDEMA, HEMATOMA, REDNESS, SWELLING, COLICKY, MASS, AND PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH EXPLANT, MULTIPLE RECURRENT VENTRAL HERNIA REPAIRS WITH IMPLANT OF NEW MESH, LYSIS OF ADHESIONS, ADMISSION TO HOSPITAL, EXCISION OF DRAINING SINUS TRACT, TPN, EVACUATION OF PURULENT FLUID COLLECTION, CT SCAN, WOUND VAC, POCKET OF INFLAMMATORY CHANGE OPENED UP AND LAVAGED, MEDICATION, PICC LINE, PCA PUMP, NG TUBE PLACEMENT, AND FISTULA REPAIR.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chills; Cramp(s) /Muscle Spasm(s); Decreased Appetite; Diarrhea; Erosion; Erythema; Fever; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hernia; Inflammation; Nausea; Nodule; Obstruction/Occlusion; Pain; Purulent Discharge; Rash; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 11825287 ↗
• InjuryMar 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, ADHESIONS, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND BOWEL RESECTION.

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

  MAUDE report 11462131 ↗
• InjuryJan 8, 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 DENSE ADHESIONS, INFECTION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Fever; Fistula; Fluid Discharge; Hernia; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11140013 ↗
• InjuryDec 21, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DRAINING ABDOMINAL WOUND WITH SEROMA SURROUNDING UNINCORPORATED MESH, PURULENT FLUID, CHRONIC MESH INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11045379 ↗
• 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 A 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, SCARRING, OPEN WOUND, MACERATED SKIN, LEAKAGE OF SUCCUS, AND INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, REVISION SURGERY, REMOVAL OF MESH, REMOVAL OF SUTURE MATERIAL, LYSIS OF ADHESIONS, ENTERECTOMY WITH PRIMARY ANASTOMOSIS, COMPONENT SEPARATION, ICU, VENTILATOR POSTOP, AND HERNIA REPAIR WITH NEW MESH.

  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; Impaired Healing; Inflammation; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10970223 ↗
• InjuryOct 20, 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 RECURRENCE, FAILURE OF MESH, MESH UNATTACHED, ADHESIONS, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; Scarring

  MAUDE report 10708619 ↗
• InjuryAug 10, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MASSIVE RECURRENT HERNIA DUE TO FAILURE OF THE MESH AND EXTENSIVE DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF ADHESIONS AND MESH REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Failure of Implant; Hernia; Injury; Unspecified Tissue Injury

  MAUDE report 10384669 ↗
• InjuryMar 26, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BACTERIAL INFECTION, OPEN WOUND, ABDOMINAL FLUID, ABDOMINAL AIR, ABDOMINAL SKIN THICKENING, DIASTASIS, MESENTERIC FAT, METABOLIC ACIDOSIS, RESPIRATORY FAILURE, ILEUS, SEPSIS, BOWEL PERFORATION, ANEMIA, LOSS OF DOMAIN, FIBROSIS, PURULENT MATERIAL DRAINAGE, FECAL DRAINAGE, MESH NOT INCORPORATED, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, INCIDENTAL APPENDECTOMY, ADMITTED TO HOSPITAL, IV FLUIDS, IV PRESSORS, ANTIBIOTICS, TPN, TRANSFUSION, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, MESH REMOVAL, SUTURES REMOVED, AND SKIN GRAFT.

  Patient problems: Adhesion(s); Anemia; Ascites; Bacterial Infection; Bowel Perforation; Discharge; Fibrosis; Hernia; Impaired Healing; Injury; No Code Available; Obstruction/Occlusion; Purulent Discharge; Respiratory Failure; Sepsis

  MAUDE report 9882632 ↗
• InjuryMar 6, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH, ADHESIONS AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, AND ADDITIONAL IMPLANT.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury

  MAUDE report 9801088 ↗
• InjuryMar 6, 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 ADHESIONS, RECURRENCE, SCARRING AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY AND ADDITIONAL IMPLANTS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hematoma; Hernia; Impaired Healing; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9800919 ↗
• 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH INFECTION DUE TO FAILURE OF THE MESH AND INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Failure of Implant; Inflammation; Injury; Unspecified Infection

  MAUDE report 9799905 ↗
• InjuryJan 22, 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 UMBILICAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SWISS CHEESE DEFECT, NECROSIS, INFLAMMATION, INFECTION, ABSCESS, OPEN DRAINING WOUND, SCARRING AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ABDOMINAL WALL RECONSTRUCTION, PARTIAL EXPLANT OF THE SURGICAL MESH AND BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Discharge; Hernia; Impaired Healing; Inflammation; Injury; Necrosis; Scarring; Unspecified Infection

  MAUDE report 9618158 ↗
• 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 A 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, AND BOWEL OBSTRUCTION. POST-IMPLANT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, HERNIA REPAIR WITH NEW MESH, AND BILATERAL COMPONENT SEPARATION.

  Patient problems: Abdominal Distention; Adhesion(s); Calcium Deposits/Calcification; Failure of Implant; Fibrosis; Hernia; Injury; Obstruction/Occlusion

  MAUDE report 9610286 ↗
• InjuryOct 18, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTIONS, BLEEDING, FISTULAS SEROMA, PERFORATION, ABSCESS, SEPSIS, NECROSIS, INFECTED MESH, AN AREA OF PERSISTENT DRAINAGE, SINUS TRACTS AND UNINCORPORATED MESH, NECROTIC TERMINAL ILEUM WITH ENTEROCUTANEOUS FISTULA TO THE RIGHT FLANK, INCARCERATED HERNIA, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL SURGERY, MEDICATION, NURSING CARE AFTER SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discharge; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Injury; Necrosis; No Code Available; Obstruction/Occlusion; Pain; Perforation; Sepsis; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9210031 ↗
• InjurySep 30, 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 LARGE RECURRENT INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 9137637 ↗
• InjurySep 30, 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 RIGHT INGUINAL HERNIA, LEFT INGUINAL AND AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT RECURRENCE, SIGNIFICANT SCAR TISSUE, SMALL PROTRUSIONS OF PREPERITONEAL FAT THROUGH INTERNAL RING, PERSISTENT GROIN PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LICHTENSTEIN REPAIR, EXCISION OF ILIOINGUINAL NERVE, AND OPEN GROIN EXPLORATION WITH HERNIA REPAIR.

  Patient problems: Hernia; Injury; No Code Available; Pain; Scar Tissue

  MAUDE report 9137589 ↗
• InjurySep 17, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, UPPER ABDOMINAL BULGE WITH OBVIOUS BOWEL CONTENT, INCREASINGLY TENDER, NAUSEA, INFECTION, PAIN, DISTENTION, INTERMITTENT VOMITING, DENSE ADHESIONS, CHRONIC OBSTRUCTION AND PERIUMBILICAL NECROSIS. POST OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Hernia; Injury; Nausea; Necrosis; Obstruction/Occlusion; Pain; Unspecified Infection; Vomiting

  MAUDE report 9074351 ↗
• InjurySep 11, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Material Perforation; 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 GIAN VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PERFORATION, SEVERE ABDOMINAL AND GROIN PAIN, BOWEL OBSTRUCTIONS REQUIRING HOSPITALIZATION, FECAL INCONTINENCE, AND DENSE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTIONS, EXTENSIVE LYSIS OF ADHESIONS, CREATION OF END ILEOSTOMY AND MUCOUS FISTULA, EXPLORATORY LAPAROTOMY, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Incontinence; Injury; Internal Organ Perforation; Obstruction/Occlusion; Pain

  MAUDE report 8987624 ↗
• 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 LAPAROSCOPIC INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION, RECURRENCE, DEHYDRATION, ABDOMINAL PAIN, NAUSEA, VOMITING, DIARRHEA, CRAMPS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ENDOSCOPIC COMPONENT SEPARATION REPAIR OF THE ABDOMINAL WALL, INCISIONAL/VENTRAL REDUCIBLE HERNIA REPAIR WITH MESH, AND LYSIS OF ADHESIONS. IT WAS NOTED THAT NO FURTHER SURGERY WAS ADVISABLE.

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

  MAUDE report 8686621 ↗