PermacolRecalls & reported problems across all models

We found 16 models of Permacol by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 311 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2013 and Jun 6, 2025 — classified as 1 death, 309 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (70 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Permacol problems

Permacol models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Permacol P101015

  Mesh, surgical
  43 reports
• Permacol P151520

  Mesh, surgical
  41 reports
• Permacol P152030

  Mesh, surgical
  41 reports
• Permacol P101010

  Mesh, surgical
  35 reports
• Permacol P101520

  Mesh, surgical
  29 reports
• Permacol P101828

  Mesh, surgical
  27 reports
• Permacol P151828

  Mesh, surgical
  26 reports
• Permacol P151015

  Mesh, surgical
  1 death24 reports
• Permacol P151020

  Mesh, surgical
  16 reports
• Permacol P100510

  Mesh, surgical
  7 reports
• Permacol P152840

  Mesh, surgical
  7 reports
• Permacol P152050

  Mesh, surgical
  6 reports
• Permacol P100055

  Mesh, surgical
  4 reports
• Permacol P151010

  Mesh, surgical
  2 reports
• Permacol P152040

  Mesh, surgical
  2 reports
• Permacol P100205

  Mesh, surgical
  1 report

Recent Permacol adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RECURRENCE, ADHESIONS, CALCIFICATION, FOREIGN BODY REACTION, DISFIGUREMENT, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, WOUND CLOSURE, WOUND VAC.

  Patient problems: Adhesion(s); Calcium Deposits/Calcification; Deformity/ Disfigurement; Emotional Changes; Foreign Body Reaction; Hernia; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury

  MAUDE report 22159167 ↗
• InjuryMar 3, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, OBSTRUCTIONS, BOWEL ISSUES, MESH FAILURE, INFECTION, FISTULA, ADHESIONS, CHRONIC PAIN, HEMATOMA, LABS ABNORMAL FOR RBC; HEMOGLOBIN; HEMATOCRIT; ALBUMIN; BUN; GLUCOSE; PHOSPHOROUS, FLUID COLLECTION, SEROMA, FOREIGN BODY GIANT CELL REACTION, SUTURE GRANULOMA, FIBROADIPOSE TISSUE, ULCERATION, INFLAMMATION, MUCOSA SHOWS FOCI OF SUPERFICIAL EROSION, GAS PAINS, CONSTIPATION, ABDOMINAL PAIN, DISCOMFORT, BLOOD DRAINAGE FROM UMBILICAL INCISION, FEVER, DIARRHEA, PURULENT DISCHARGE, MESH UNINCORPORATED <(>&<)> FLOATING, ILEUM <(>&<)> COLON DILATED, COLON THINNER WALLED, ENTERIC CONTENTS DRAINING FROM VAGINA, SEXUAL INTERCOURSE UNCOMFORTABLE, SEROSAL TEARS, THIN APEX OF VAGINA, RETAINED STOOL, EROSION OF MESH INTO BOWEL, SCARRING, <(>&<)> ATTENUATED MUSCLE FASCIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, REVISION SURGERY, SMALL BOWL RESECTION, COLON RESECTION, WOUND VAC, CT SCAN, PHYSICAL THERAPY, IV FLUID, MEDICATION, MULTIPLE HOSPITALIZATIONS, EVACUATION OF HEMATOMA, IV H

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Constipation; Diarrhea; Discomfort; Electrolyte Imbalance; Erosion; Fever; Fistula; Flatus; Foreign Body Reaction; Granuloma; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Seroma; Sexual Dysfunction; Ulcer; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21506465 ↗
• InjuryNov 26, 2024Migration 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 DETACHMENT, PAIN, INFLAMMATION, ADHESIONS, OBSTRUCTION, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, AND BOWEL RESECTION.

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

  MAUDE report 20788071 ↗
• InjuryOct 9, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, OBSTRUCTION, ADHESIONS, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 20408670 ↗
• InjuryMay 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, INFLAMMATION, SCARRING, MESH COMPLICATION INJURIES. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 19332272 ↗
• 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 ↗
• InjuryJun 14, 2023Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 SINUS TRACT, ABDOMINAL WALL MASS, VASCULAR CONGESTION, SEROUS DRAINAGE,NON-HEALING WOUND, PURULENT DISCHARGE, ABDOMINAL PAIN, ADHESIONS, INFECTION, FISTULA, MASS, TENDERNESS, ERYTHEMA, SEROMA, HEMATOMA, SWELLING, ABSCESS, FOREIGN BODY REACTION, FIBROSIS, INFLAMMATION, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIALREMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION, HOSPITALIZATION, DEBRIDEMENT OF ANTERIOR ABDOMINAL WALL SINUS TRACT, PLACEMENT OF WOUND VAC, LYSIS OF ADHESIONS, SEGMENTAL ENTERECTOMY WITH ANASTOMOSIS, REMOVAL OF TACKS, PLACEMENT OF DRAINS, INCISION/DRAINAGE OF ABSCESS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Erythema; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hernia; Impaired Healing; Inflammation; Nodule; Obstruction/Occlusion; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Unspecified Vascular Problem

  MAUDE report 17127604 ↗
• InjuryMay 4, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 16870889 ↗
• InjuryMar 23, 2023Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED ACUTE CHRONIC PAIN, INFECTION, HERNIA RECURRENCE, HEMATOMA, INFLAMMATION, ALLERGIC REACTION, ADHESIONS, OBSTRUCTIONS, BLEEDING, FISTULAS, SEROMA, PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPAIR OF SMALL BOWEL FISTULA WITH PRIMARY REPAIR OF VENTRAL HERNIA, BOWEL REMOVAL, MESH REMOVAL, COLOSTOMY BAG PLACEMENT, MEDICATION, PREVIOUS BIOLOGIC MESH WAS NOTED AND INCISED.

  Patient problems: Adhesion(s); Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16600951 ↗
• InjuryJan 3, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, OBSTRUCTION, FISTULA, MASS, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, BOWEL RESECTION, LYSIS OF ADHESIONS, RESECTION OF ABDOMINAL MASS, REVISION SURGERY, MESH REVISION, LAPAROTOMY, AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Impaired Healing; Necrosis; Nodule; Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16091464 ↗
• InjuryDec 29, 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 OBSTRUCTION, SEROMA, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, FAILURE OF MESH, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, DEFECTIVE MESH, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, REVISION SURGERY, SMALL BOWEL RESECTION, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Emotional Changes; Hernia; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16069830 ↗
• InjuryDec 19, 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Constipation; Diarrhea; Hernia; High Blood Pressure/ Hypertension; Nausea; Obstruction/Occlusion; Pain; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 16003844 ↗
• InjuryNov 29, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, FISTULAS, AND BULGING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, JP DRAIN, AND MEDICATION.

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

  MAUDE report 15881418 ↗
• InjuryNov 15, 2022Migration 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, SMALL BOWEL OBSTRUCTION, PAIN, MESH EROSION, MESH MIGRATION, FIBROMEMBRANOUS TISSUE WITH MESOTHELIAL-LINING, INFLAMMATION, REDNESS, SWELLING, DRAINAGE, INDURATION, NAUSEA, VOMITING, CHILLS, CONSTIPATION, DIARRHEA, DRAINING EXUDATE, DEEP TRACT, ABDOMINAL PAIN, FEVER, LOOSE BOWEL MOVEMENTS, ABSCESS, AND ENTEROTOMY. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, CT SCAN, ADMISSION TO HOSPITAL, MEDICATION, ABDOMINAL WOUND DEBRIDEMENT, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, REPAIR OF ENTEROTOMY, LYSIS OF ADHESIONS, EXCISION OF WOUND TRACT, AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Constipation; Diarrhea; Erosion; Erythema; Fever; Fistula; Fluid Discharge; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Perforation; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 15800927 ↗

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