Parietex PCO12FXRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521179738), received between Oct 16, 2018 and May 18, 2026 — classified as 19 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER ON (B)(6) 2026, POST-OPERATIVE OF A LAPAROSCOPIC SUPRAPUBIC EVENTRATION PROCEDURE PERFORMED ON (B)(6) 2019 WHERE A 12 CM IN DIAMETER MESH WAS IMPLANTED, THE PATIENT WAS ADMITTED FOR ACUTE INTESTINAL OBSTRUCTION ON THE SMALL INTESTINE. AN EXPLORATORY LAPAROSCOPY WAS PERFORMED ON THE SAME DAY. THE PROCEDURE REVEALED SIGNIFICANT EPIPLOIC ADHESIONS LOCATED DIRECTLY ON THE PROSTHETIC PLATE. DESPITE THE FIRST INTERVENTION, THE OCCLUSIVE CONDITION PERSISTED WITH AN ASCENT OF A C-REACTIVE PROTEIN (CRP) INFLAMMATION. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2026 SHOWED THE PERSISTENCE OF THE INTESTINAL OBSTRUCTION WITH JUNCTIONAL SYNDROME RATHER IN THE RIGHT ILIAC FOSSA. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6) 2026. TWO DAYS LATER, THE PATIENT UNDERWENT A MAJOR OPERATION BY SUBUMBILICAL MEDIAN LAPAROTOMY. THE SURGEONS THEN NOTED INCARCERATION OF THE SMALL INTESTINE LINKED TO THE PROSTHESIS. THERE WERE MASSIVE ADHESIONS REQUIRING COMPLEX ADHESIOLYSIS. THE PROSTHESIS PLATE HAD TO BE COMPLETELY REMOVED. A SEGMENTAL RESECTION OF ABOUT 3 CM OF SMALL INTESTINE AT 50 CM FROM THE ILEOCECAL VALVE WITH MANUAL LATERO-LATERAL ANASTOMOSIS WAS DONE.

  Patient problems: Adhesion(s); Anxiety; Chest Pain; Fatigue; Inflammation; Obstruction/Occlusion; Pelvic Pain; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 25197396 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENTRAL HERNIA REPAIR OPERATION WITH IMPLANTATION OF A MESH PROSTHESIS WAS PERFORMED, AND ON THE EVENING OF DISCHARGE THE PATIENT EXPERIENCED FEVER, INTENSE ¿ELECTRICAL STABS¿ PAIN, AND INABILITY TO WALK. THE PATIENT RETURNED THE NEXT DAY AND UNDERWENT A COMPUTED TOMOGRAPHY SCAN, RECEIVED TRAMADOL FOR PAIN MANAGEMENT, AND WAS DISCHARGED DESPITE ONGOING PAIN. THE PAIN PERSISTED WITH INTENSE GROIN AND LOWER ABDOMINAL PAIN AND SLEEP DISTURBANCE, AND THE PATIENT LATER WORSENED AND WAS SENT TO THE EMERGENCY ROOM WHERE BLOOD TESTS AND COMPUTED TOMOGRAPHY IMAGING IDENTIFIED INFLAMMATION, INFECTION, AND A WHITE LIQUID UNDER THE PROSTHESIS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH AMOXICILLIN, MORPHINE, PARACETAMOL, AND ACUPUNCTURE. THE PROSTHESIS WAS REMOVED AND REPLACED WITH ANOTHER PROSTHESIS, AFTER WHICH THE PAIN CALMED DOWN AND THE PATIENT WAS DISCHARGED. RECURRENT PAIN WAS REPORTED LATER ALONG WITH FATIGUE/EXHAUSTION, AND A PHYSICIAN PRESCRIBED BLOOD TESTS AND A COMPUTED TOMOGRAPHY SCAN TO EVALUATE WHETHER INFECTION AND INFLAMMATION WERE STILL PRESENT. THE PATIENT ALSO REPORTED LOSS OF TRUST IN THE SURGEONS AND ALLEGED INACCURATE ORAL EXPLANATIONS AND REPOR

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Fever; Inflammation; Pain; Sleep Dysfunction; Tissue Breakdown; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 24917960 ↗
• MalfunctionApr 17, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT UNDERWENT AN IMPLANT PROCEDURE, INVOLVING THE PLACEMENT OF A MESH FOR VENTRAL HERNIA REPAIR. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN DESCRIBED AS ¿LIKE SCISSOR BLOWS INSIDE,¿ ALONG WITH OVERWHELMING AND CONTINUOUS FATIGUE. THE INDIVIDUAL ALSO REPORTEDLY HAD DIFFICULTY WALKING, DIFFICULTY PERFORMING DAILY ACTIVITIES/GESTURES (SUCH AS CLEANING AND TYING LACES), INABILITY TO CARRY EVEN A SLIGHT LOAD, AND PREMATURE FATIGUE WITH MINIMAL EXERTION.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Discomfort; Fatigue

  MAUDE report 24913296 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED DURING A SURGICAL PROCEDURE FOR THE THIRD RECURRENCE OF UMBILICAL HERNIA, FOLLOWING TWO PREVIOUS REPAIRS WITHOUT REINFORCEMENT AND ONE WITH REINFORCEMENT. POSTOPERATIVELY, THE CHRONIC PAIN WAS PRESENT SINCE THE LAST IMPLANT. THE PATIENT EXPERIENCED INCESSANT ABDOMINAL PAIN, PAIN ON THE LEFT AND RIGHT SIDES, PAIN IN THE TESTICLES, TINGLING AND BURNING SENSATIONS, AND SENSITIVE SKIN. ADHESIONS WERE NOTED DURING SURGICAL EXPLORATION. THE PATIENT UNDERWENT MULTIPLE SURGERIES, INCLUDING TWO OPERATIONS IN (B)(6) 2025, AND REQUIRED A LONG DURATION OF SICK LEAVE DUE TO PSYCHOLOGICAL IMPACT. A SCAN WAS PERFORMED AND LYRICA TREATMENT WAS IN PROGRESS.

  Patient problems: Abdominal Pain; Burning Sensation; Distress; Hernia; Pain; Skin Burning Sensation

  MAUDE report 24849418 ↗
• MalfunctionMar 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT AN UMBILICAL HERNIA SURGERY BY LAPAROSCOPY WITH MESH IMPLANT IN (B)(6) 2024. DURING DIAGNOSTIC LAPAROSCOPY. CREATION OF THE PNEUMOPERITONEUM BY LEFT SUBCOSTAL PUNCTURE. INTRODUCTION OF OPTICS AND TWO OPERATING TROCARS IN THE LEFT FLANK AND IN FIG. THERE IS INDEED A LARGE HERNIA OF THE WHITE LINE WITH INVAGINATION OF PART OF THE ROUND LIGAMENT. ONCE THE DIAGNOSIS IS CONFIRMED, THE TREATMENT IS CONSIDERED TO BE CARRIED OUT LAPAROSCOPICALLY. REDUCTION OF THE CONTENTS BY GENTLE AND PROGRESSIVE TRACTION, AT THE SAME TIME AS THE HERNIA SAC IS OPENED ON ITS LEFT SIDE. REINTEGRATION OF THE ROUND LIGAMENT AND THE LIPOMA THAT REMAINS APPENDED TO IT IN THE LARGE PERITONEAL CAVITY. THE PARIETAL REPAIR IS CARRIED OUT BY A CIRCULAR PROLENE PROSTHESIS MESH FIXED TO THE POSTERIOR SURFACE OF THE MUSCLE WALL BY ABSORBABLE STAPLES. THIS PROSTHESIS IS SEPARATED FROM THE VISCERAL MASS BY THE GREAT OMENTUM. EXSUFFLATION OF THE PERITONEAL PNO AFTER REMOVAL OF THE INSTRUMENTS AND SUTURING OF THE SKIN WITH STAPLES. PARIETAL PAIN ON AWAKENING FROM THE OPERATION. THIS PAIN HAS SINCE BEEN TREATED (BY ADJUSTMENT) WITH ANALGESICS AND WILL BE TREATED BY A PAIN CEN

  Patient problems: Pain

  MAUDE report 24661552 ↗
• InjuryNov 26, 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 PAIN, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 23658666 ↗
• MalfunctionNov 20, 2025Delivered as Unsterile Product; Packaging Problem; Material Split, Cut or Torn; Delivered as Unsterile Product; Packaging Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE IN A HERNIA PROCEDURE, THE MESH WAS DAMAGED. UPON OPENING THE SEALED BOX IN THE OPERATING ROOM, THE MESH INSIDE APPEARED TO HAVE BEEN OPENED BEFORE. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602831 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A MESH DURING A LAPAROSCOPIC SURGICAL REPAIR FOR UMBILICAL EVENTRATION, THE INDIVIDUAL EXPERIENCED CHRONIC, SEVERE ABDOMINAL PAIN BOTH DAY AND NIGHT, WHICH DID NOT IMPROVE AND BECAME UNBEARABLE. THE PAIN RESULTED IN SIGNIFICANT FUNCTIONAL IMPAIRMENT, PREVENTING THE RESUMPTION OF NORMAL DAILY ACTIVITIES AND SEVERELY IMPACTING QUALITY OF LIFE. MULTIPLE MEDICAL VISITS AND EXAMINATIONS WERE CONDUCTED.

  Patient problems: Abdominal Pain

  MAUDE report 22320848 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A PARIETAL REINFORCEMENT IMPLANT IN (B)(6) 2018 WITH SUSPECTED REJECTION OF THE IMPLANT SINCE (B)(6) 2024, THE PATIENT HAD A PERSISTENT ABDOMINAL PAIN, NAUSEA, AND 15 KG WEIGHT LOSS FOR SEVERAL MONTHS. SEVERELY IMPAIRED QUALITY OF LIFE. THE PATIENT RECEIVED TREATMENT AT THE CLINICAL PAIN CENTER.

  Patient problems: Nausea; Weight Changes

  MAUDE report 22154977 ↗
• MalfunctionMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER A MESH WAS IMPLANTED IN A FEMALE PATIENT, FOR THE TREATMENT OF AN EVENTRATION AND APPENDICITIS. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT PAIN ON THE ENTIRE RIGHT SIDE OF HER BODY, RADIATING UNDER THE RIBS, TO THE BACK, AND ABOVE THE SHOULDER AND REPORTED AN INABILITY TO BEND FORWARD DUE TO THE INTENSITY OF THE PAIN. IT WAS ALSO NOTED THAT THERE WAS A PERSISTENT SENSATION OF THE MESH INSIDE THE PATIENT'S ABDOMEN. AS OF THREE YEARS POST-IMPLANTATION, THE PATIENT CONTINUES TO SUFFER FROM DAILY PAIN, A HIGH CRP LEVEL AND ONGOING FUNCTIONAL LIMITATIONS WITH NO REPORTED RESOLUTION OR CORRECTIVE INTERVENTION NOTED IN THE CASE FILE.

  Patient problems: Pain

  MAUDE report 22050742 ↗
• InjurySep 14, 2023Migration 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, PAIN, MESH EROSION, MESH MIGRATION, AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Adhesion(s); Erosion; Hernia; Nerve Damage; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17751413 ↗
• InjuryDec 8, 2022Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INCARCERATION OF HERNIA, DISPLACED MESH, RIPPED MESH, PAIN, RECURRENCE, AND ADHESIONS.

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

  MAUDE report 15946097 ↗
• MalfunctionAug 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) UMBILICAL HERNIA REPAIR, WHILE FIXATING A 1 CM DEFECT, FOUR FIXATION POINTS WERE APPLIED BUT THE MESH WOULD NOT FIX WELL. THE TACKER WOULD NOT FIRE TACKS NORMALLY AS WELL. ANOTHER MESH AND TACKER WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245323 ↗
• InjuryJun 16, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ABSCESS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14718242 ↗
• InjuryMay 28, 2021Mechanics 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL TENDERNESS, RECURRENCE, SCARRING, MENTAL PAIN, PAIN, INJURY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11900625 ↗
• InjuryOct 20, 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 INGUINAL HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PHYSICAL PAIN, MENTAL ANGUISH, DISABILITY, PSYCHOLOGICAL STRESS, DEPRESSION, LOSS OF ENJOYMENT OF LIFE, AND INJURED SEVERELY/PERMANENTLY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, AND HOSPITALIZATIONS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Depression; Disability; Discomfort; Distress; Emotional Changes; Granuloma; Hernia; Injury; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 10705701 ↗
• InjurySep 29, 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 THE IMPLANT, THE PATIENT EXPERIENCED SEVERE PERMANENT INJURY, PHYSICAL PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION AND DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATIONS, REPAIR SURGERY, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Depression; Disability; Distress; Emotional Changes; Fibrosis; Hernia; Injury; Ischemia; Nausea; Necrosis; Nodule; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 10603238 ↗
• InjurySep 29, 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 THE IMPLANT, THE PATIENT EXPERIENCED SEVERE PERMANENT INJURY, PHYSICAL PAIN, MENTAL ANGUISH, PSYCHOLOGICAL STRESS, DEPRESSION, DEFECTIVE MESH, LOSS OF ENJOYMENT OF LIFE, AND DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATIONS, REPAIR SURGERY, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Depression; Disability; Distress; Emotional Changes; Fibrosis; Hernia; Injury; Ischemia; Nausea; Necrosis; Nodule; Obstruction/Occlusion; Pain; Unspecified Tissue Injury; Vomiting

  MAUDE report 10598992 ↗
• InjuryApr 24, 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 SEVERE PAIN, GASTROINTESTINAL MALFUNCTION, GROTESQUE SWELLING, MESH FAILURE, SCARRING, DISFIGUREMENT, LOSS OF ENJOYMENT OF LIFE, PERMANENT PHYSICAL DISABILITY, LOSS OF PHYSICAL, MENTAL AND EMOTIONAL HEALTH, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Disability; Discomfort; Emotional Changes; Erythema; Failure of Implant; Fever; Hernia; Injury; No Code Available; Pain; Scar Tissue; Scarring; Swelling; Swelling/ Edema; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 9997372 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PERMANENT INJURY, PAIN, DISABILITY, MENTAL ANGUISH, STRESS, AND DEPRESSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION AND ADDITIONAL SURGERIES.

  Patient problems: Ascites; Depression; Disability; Distress; Emotional Changes; Hernia; Injury; Muscle Weakness/Atrophy; Pain; Sleep Dysfunction; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8689446 ↗
• InjuryMay 3, 2019Material 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, BULGE, TENDERNESS, PAIN, MESH PUCKERED, INFECTION, INFLAMMATION, SCARIFICATION, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH AND MESH DEFORMATION. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH MESH AND LYSIS OF ADHESIONS. THE DEVICE HAS BEEN USED WITH UNKNOWN PROTACKER

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Foreign Body Reaction; Hernia; Inflammation; Injury; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8579057 ↗
• InjuryApr 2, 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 RECURRENT INCISIONAL HERNIA REPAIRED WITH MESH, RECURRENT BOWEL OBSTRUCTIONS, ABDOMINAL PAIN, ABDOMINAL ADHESIONS, INTESTINAL ADHESIONS, LOOPS OF SMALL BOWEL WERE CHRONICALLY INCARCERATED WITHIN VENTRAL INCISIONAL HERNIA, AND PARTIAL EXCISION OF OLD MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Injury; No Code Available; Obstruction/Occlusion

  MAUDE report 8472928 ↗
• InjuryJan 15, 2019Migration 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 LAPAROSCOPIC VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, EXTENSIVE ADHESIONS, BOWEL ATTACHED TO INTRA-ABDOMINAL MESH, CHOLECYSTITIS, CHOLELITHIASIS, DISCOMFORT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, LAPAROSCOPIC CHOLECYSTECTOMY, LYSIS OF ADHESIONS, REPAIR OF MIDLINE INCISIONAL HERNIA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Injury; No Code Available; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8250854 ↗
• InjuryOct 16, 2018Adverse 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 MULTIPLE RECURRENT INCARCERATED HERNIAS DUE TO FAILURE OF THE MESH, EXTENSIVE ADHESIONS OF SMALL BOWEL, LARGE BOWEL AND OMENTUM TO THE MESH, AND MULTIPLE REVISION SURGERIES.

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

  MAUDE report 7970921 ↗