Parietene PPM4530Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521213791), received between Apr 2, 2018 and Jul 30, 2026 — classified as 2 deaths, 45 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (10 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse 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, hernia recurrence, inflammation, obstruction, abdominal pain, constipation. Post-operative patient treatment included medication.

  Patient problems: Abdominal Pain; Constipation; Hernia; Inflammation; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 50089544 ↗
• InjuryApr 3, 2026Adverse 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 BOWEL OBSTRUCTION, PAIN.

  Patient problems: Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 24778898 ↗
• InjuryMar 31, 2026Adverse 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: Unspecified Tissue Injury

  MAUDE report 24750020 ↗
• InjuryDec 17, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, AND NUMBNESS IN STOMACH AREA.

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

  MAUDE report 23830160 ↗
• InjuryNov 3, 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, MIGRATION, PAIN, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23454072 ↗
• InjuryAug 4, 2025Material 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, MUSCLE SPASMS AND MESH EVENTRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 22705691 ↗
• InjuryJun 24, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, FISTULA, SEROMA, PERFORATION, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, MEDICATION, EXPLORATORY LAPAROTOMY, ABDOMINAL WASHOUT, PARTIAL TRANSVERSE COLECTOMY, END COLOSTOMY, BOWEL RESECTION AND WOUND VAC.

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

  MAUDE report 22320821 ↗
• InjuryApr 22, 2025Material 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, STABBING SENSATION, PULLING SENSATION, AND MESH CONTRACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 21884619 ↗
• InjuryFeb 12, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Nerve Damage; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 21368114 ↗
• MalfunctionOct 31, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE SURGEON STATED THAT THE MESH WAS IMPLANTED ONE YEAR AFTER A TRANSVERSE ABDOMINUS RELEASE HAD SPLIT IN HALF. HE STATED THE BREAK WAS RIGHT IN THE CENTER OF THE MESH. THE PATIENT UNDERGONE CHEMOTHERAPY OR RADIATION TREATMENTS AND AN ADDITIONAL OPERATION TO CORRECT THE ISSUE.

  Patient problems: Hernia; Insufficient Information; Unintended Radiation Exposure

  MAUDE report 20578522 ↗
• InjurySep 17, 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, PAIN, RECURRENCE, ABDOMINAL PAIN, AND BOWEL PERFORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION, DEBRIDEMENT, REMOVAL OF ENTIRE INFECTED MESH, AND MEDICATION.

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

  MAUDE report 20240991 ↗
• InjurySep 17, 2024Material 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH CONTRACTION, BOWEL INJURY. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, MEDICATION.

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

  MAUDE report 20239736 ↗
• InjurySep 12, 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 VENTRAL AND AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MEDICATION.

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

  MAUDE report 20204968 ↗
• InjuryJul 2, 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, FISTULA, ADHESIONS, FIBROSIS, ABSCESS, NECROSIS, PURULENT DISCHARGE, BACTERIAL INFECTION, DRAINING SINUS TRACT, EXPOSED MESH, MESH EROSION, SKIN DISCOLORATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, WOUND VAC, INCISIONS AND DRAINAGE, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, REVISION SURGERY, AND PARTIAL MESH EXPLANT.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Erosion; Fibrosis; Fistula; Fluid Discharge; Hernia; Necrosis; Pain; Purulent Discharge; Skin Discoloration; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19657760 ↗
• InjuryJun 3, 2024Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH MIGRATION, MESH PERITONEALIZED AND EVENTRATED INTO HERNIA DEFECT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH DISSECTED FREE FROM HERNIA DEFECT.

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

  MAUDE report 19449358 ↗
• InjuryNov 17, 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, INFECTION, INFLAMMATION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18161317 ↗
• InjurySep 6, 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 MULTIPLE VENTRAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ILEUS, PATIENT STATED "LIFE IS MISERABLE", LIPOMA, ABDOMINAL PAIN, NAUSEA, DIARRHEA, DISTENTION, ADHESIONS, VOMITING, FLUID COLLECTIONS, SMALL BOWEL OBSTRUCTION, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED DIAGNOSTIC LAPAROSCOPY, LAP LYSIS OF ADHESIONS, HOSPITAL ADMISSION, IV FLUIDS, CLEAR LIQUID DIET, AGGRESSIVE BOWEL REGIMEN INCLUDING SUPPOSITORY, NG TUBE, LIPOMA TO ABDOMINAL WALL PALPATED, PAIN MANAGEMENT, CT SCANS, ABDOMINAL X-RAY, ANTINAUSEA MEDICATION, AND SERIAL X-RAYS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Emotional Changes; Nausea; Obstruction/Occlusion; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 17691682 ↗
• InjuryAug 16, 2023Adverse 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Constipation; Decreased Appetite; Distress; Dysuria; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Scar Tissue; Sexual Dysfunction; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 17561210 ↗
• InjuryJul 10, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, ADHESIONS, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY <(>&<)> MESH REMOVAL.

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

  MAUDE report 17293959 ↗
• InjuryJun 1, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanics Altered; 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ABDOMINAL PAIN, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR.

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

  MAUDE report 17039290 ↗
• InjuryMar 6, 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 CHRONIC PAIN, RECURRENCE, INFLAMMATION, OBSTRUCTION, SEROMA, NAUSEA, VOMITING, UNABLE TO DIGEST FOOD, SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 16487599 ↗
• InjuryFeb 9, 2023Material 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 VENTRAL/INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUFFERING, SEROSAL TEARS, MESH EVENTRATION, BOWEL PROBLEMS, EXPOSURE, EXTRUSION OR PROTRUSION, NEUROMUSCULAR PROBLEMS, URINE SOMETIMES HAS TOXIC SMELL, ADHESIONS, RECURRENCE, PAIN, SEROMA, EMOTIONAL PROBLEMS, FECAL OR URINARY INCONTINENCE, FISTULA, ORGAN PERFORATION, NERVE DAMAGE, INFLAMMATION, MESH CONTRACTION, MESH EROSION, BOWEL OBSTRUCTION, INFECTION, ABDOMINAL PAIN, MULTIPLE DISTENDED LOOPS OF SMALL BOWEL, MESENTERIC EDEMA, ABSCESS, ENTERITIS, FREE FLUID, GASEOUS DILATION, ILEUS, BULGING, DISTENTION, VOMITING, TACHYCARDIA, FEVER, SCARRING, SWELLING, CONSTIPATION, BLOATING, NAUSEA, TENDERNESS, BURNING, DIASTASIS, DYSURIA, <(>&<)> WEAKNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, CT SCAN, HERNIA REPAIR WITH MESH, X-RAY, AMBULATION, IV FLUIDS, ANTIBIOTICS, PAIN MEDICATION, ANTI-NAUSEA MEDICATION, NPO [NOTHING BY MOUTH], NG TUBE, TPN [TOTAL PARENTERAL NUTRITION], PHYSICAL THERAPY, SUPPLEMENTAL OXYGEN, PICC LINE PLACEMENT, JP DRAINS X 2, HOSPITALIZATIO

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Burning Sensation; Constipation; Discomfort; Dysuria; Emotional Changes; Erosion; Fever; Fistula; Hernia; Incontinence; Inflammation; Muscle Weakness/Atrophy; Nausea; Nerve Damage; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Seroma; Swelling/ Edema; Tachycardia; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 16339293 ↗
• InjuryFeb 2, 2023Material 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NECROTIC TISSUE, HARD MASS, INFLAMMATION, DRAINAGE, SEROMA, ABSCESS, ADHESIONS, MESH SHRINKAGE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH PARTIALLY REMOVED, ABSCESS INCISION AND DRAINAGE SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cellulitis; Chest Pain; Chills; Discomfort; Dizziness; Dyspnea; Embolism/Embolus; Fever; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Inflammation; Muscle Weakness/Atrophy; Necrosis; Nodule; Pain; Pneumonia; Purulent Discharge; Seroma; Sexual Dysfunction; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 16287222 ↗
• DeathDec 22, 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 MENTAL PAIN, PHYSICAL DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, MENTAL ANGUISH, PAIN, NECROTIC TISSUE, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED ICU VISIT, INTUBATION, SEDATION, NECROTIC TISSUE DEBRIDEMENT, WOUND VAC, AND REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Emotional Changes; Hernia; High Blood Pressure/ Hypertension; Impaired Healing; Necrosis; Pain; Renal Failure; Respiratory Failure; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16040565 ↗
• DeathDec 22, 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 MENTAL PAIN, PHYSICAL DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISFIGUREMENT, MENTAL ANGUISH, PAIN, RECURRENCE, NECROTIC TISSUE, HYPERTENSION, ABDOMINAL COMPARTMENT SYNDROME, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF PARIETENE, PLACEMENT OF VICRYL MESH, HERNIA REPAIR WITH PARIETENE, ICU VISIT, INTUBATION, SEDATION, NECROTIC TISSUE DEBRIDEMENT, WOUND VAC, AND REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bruise/Contusion; Deformity/ Disfigurement; Emotional Changes; Hernia; High Blood Pressure/ Hypertension; Impaired Healing; Necrosis; Pain; Renal Failure; Respiratory Failure; Seroma; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16040390 ↗