Parietene PPM3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521213784), received between Jul 9, 2018 and May 28, 2026 — classified as 47 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (16 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR PERFORMED ON (B)(6) 2022, IT WAS NOTED ON 15-MAY-2026 THAT THE MESH WAS FRACTURED AND HAD CAUSED A HERNIA RECURRENCE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REPAIR THE HERNIA RECURRENCE.

  Patient problems: Hernia

  MAUDE report 25312379 ↗
• InjuryMay 19, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25219872 ↗
• InjuryApr 29, 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 25033341 ↗
• InjuryJan 16, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 24098845 ↗
• InjuryJan 5, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23967341 ↗
• InjuryMar 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A VENTRAL HERNIA REPAIR PROCEDURE USING THE DEVICE, THE MESH WAS DESCRIBED AS FRACTURED WITH MANY HOLES DOWN THE CENTER AND APPEARED INGROWN. THE PROCEDURE WAS PERFORMED USING AN OPEN APPROACH WITH ONLAY TECHNIQUE. HERNIA RECURRED AND REPLACEMENT OF THE MESH WERE PERFORMED TO RESOLVE THE ISSUE, AND AN ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Hernia

  MAUDE report 21734560 ↗
• InjuryFeb 26, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER SUB-LAY IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, PERFORATION, WOUND DEHISCENCE, MESH EVENTRATION, MESH CONTRACTION, INTESTINAL BLOCKAGE, AND STOMACH PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND MEDICATION.

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

  MAUDE report 21472135 ↗
• InjuryJan 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, INFLAMMATION, HEMATOMA, RECURRENCE, PAIN, SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21185715 ↗
• InjuryNov 15, 2024Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, INFECTION, RECURRENCE, INFLAMMATION, HEMATOMA, PERFORATION, NERVE DAMAGE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EVACUATION OF HEMATOMA, DISSECTION OF BOWEL, WOUND VAC.

  Patient problems: Emotional Changes; Hematoma; Hernia; Inflammation; Nerve Damage; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20696229 ↗
• InjuryOct 11, 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, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 20434157 ↗
• InjurySep 13, 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, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 20215753 ↗
• InjuryFeb 9, 2024Mechanics 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS,SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, HERNIA REPAIR, LYSIS OF ADHESIONS.

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

  MAUDE report 18679552 ↗
• InjuryJul 17, 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 PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 17334012 ↗
• InjuryJun 28, 2023Mechanics 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED DILATION OF SMALL BOWEL/COLON, SEVERAL FLUID COLLECTIONS, ABNORMAL LEVELS OF ALBUMIN; BUN/CREATININE RATIO; WHITE BLOOD CELL COUNT; HEMOGLOBIN; HEMATOCRIT, GASEOUS DISTENDED LARGE BOWEL, ILEUS, PARTIAL SMALL BOWEL OBSTRUCTION, ATRIAL FIBRILLATION, RAPID VENTRICULAR RESPONSE, ACUTE RENAL FAILURE, DECREASED URINE OUTPUT, DECREASE OXYGEN SATURATION WITH AMBULATION, AND GENERALIZED WEAKNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, TRANSFER TO CVU [INTERMEDIATE CARE CARDIOVASCULAR UNIT WITH TELEMETRY], LOPRESSOR, METOPROLOL, IV AMIODARONE, IV FLUIDS, BLOOD TRANSFUSIONS, NASAL CANNULA OXYGEN, AND MORPHINE PCA. CONCOMITANT DEVICES: DAVOL MARLEX MESH 10X14; PRODUCT ID: 0112660; OVITEX MESH 15X15; PRODUCT ID: F10244-1515L.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Atrial Fibrillation; Depression; Emotional Changes; Hernia; Low Oxygen Saturation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Renal Failure; Unspecified Heart Problem; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury

  MAUDE report 17218680 ↗
• InjuryMay 10, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ABSCESS, OPEN WOUND, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, REMOVAL OF MESH, WOUND IRRIGATION, REAPPROXIMATED THE RECTUS MUSCLES, WOIUND VAC.

  Patient problems: Abdominal Pain; Abscess; Discomfort; Emotional Changes; Hernia; Impaired Healing; Incontinence; Pain; Unspecified Tissue Injury

  MAUDE report 16905623 ↗
• InjuryJan 25, 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, FIBROSIS, CHRONIC INFLAMMATION, GIANT CELL REACTION, PAIN, DEFECTIVE DEVICE, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR, LYSIS OF ADHESIONS, SMALL INTESTINE RESECTION WITH ANASTOMOSIS, AND REMOVAL OF ABDOMINAL WALL MESH.

  Patient problems: Adhesion(s); Emotional Changes; Fibrosis; Foreign Body Reaction; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16244764 ↗
• InjuryDec 6, 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 INFECTION, RECURRENCE, ADHESIONS, FISTULAS, ABSCESS, WOUND CARE, HEMATOMA, MEMORY LOSS, IMPAIRMENT, MENTAL ANGUISH, AND BOWEL REMOVAL. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION, AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Emotional Changes; Fistula; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Memory Loss/Impairment; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15924750 ↗
• InjurySep 30, 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 SMALL BOWEL OBSTRUCTION, INFECTION, RECURRENCE, ADHESIONS, NECROSIS, ACUTE KIDNEY INJURY, ABDOMINAL PAIN, BLOATING, CONSTANTLY FEELS FULL, AND NON-HEALING OPEN WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, WOUND DEBRIDEMENT, MEDICATION, ICU STAY WITH VENTILATOR USE, USE OF WITTMANN PATCH FOR ABDOMINAL WALL CLOSURE, GASTROSTOMY TUBE PLACEMENT, USE OF JP DRAIN, ABDOMINAL WASHOUT, AND WOUND CARE.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Impaired Healing; Necrosis; Obstruction/Occlusion; Renal Failure; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15515853 ↗
• InjurySep 24, 2022Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CONTRACTION, MESH MIGRATION, LACK OF ADEQUATE INGROWTH, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, DISTENTION, SCARRING, MESH ENCAPSULATION, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Dysphagia/ Odynophagia; Electrolyte Imbalance; Foreign Body Reaction; Hernia; Hypernatremia; Hypoxia; Inflammation; Muscle Weakness/Atrophy; Nausea; Nodule; Pain; Respiratory Failure; Scar Tissue; Tachycardia; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15480772 ↗
• InjurySep 24, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, OBSTRUCTION, BLEEDING, MESH MIGRATION, SCARIFICATION, MESH ENCAPSULATION, CRAMPING, SCARRING, LIMITED IN THE ACTIVITIES HE CAN DO, STOMACH MUSCLES HAVE DIMINISHED, AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15477088 ↗
• InjuryJul 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, IMPAIRMENT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

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

  MAUDE report 15135477 ↗
• InjuryJun 9, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DEFECTIVE DEVICE, MESH FAILURE, PAIN, MENTAL ANGUISH, MENTAL PAIN, EMOTIONAL DISTRESS, SUFFERING, PERMANENT IMPAIRMENT, DISABILITY, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL AND/OR REVISION OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cough; Distress; Dysuria; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 14647239 ↗
• InjuryFeb 11, 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 HERNIA. IT WAS REPORTED THAT AFTER SUBLAY IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, ADHESIONS OF THE OMENTUM; COLON; SMALL INTESTINE, HERNIA RECURRENCE, SMALL BOWEL OBSTRUCTION, IMPROPER WOUND HEALING. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, HERNIA REVISION, SURGICAL INTERVENTION.

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

  MAUDE report 13514335 ↗
• InjuryJan 21, 2022Adverse 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 SUBLAY IMPLANT, THE PATIENT EXPERIENCED MESH RUPTURE/TEAR, INFECTION, PAIN, PERSISTENT SECRETION FROM WOUND, SEROMA, INFLAMMATION, PUS, FISTULATION, ABSCESS, OPEN WOUND, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ANTIBIOTICS, HOSPITALIZATION, WOUND TREATMENT/SPLICING/WASH, PUS WAS EMPTIED, AND MESH SEWED WITH ABSORBABLE SUTURES WHILE LEAVING IT IN PLACE.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Erythema; Fistula; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Pain; Pleural Effusion; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13314039 ↗
• 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND ADHESIONS.

  Patient problems: Emotional Changes; Hernia; Impaired Healing; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12652720 ↗