Parietex PCO2H3Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521178465), received between Nov 1, 2017 and Jun 30, 2023 — classified as 1 death, 26 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REVISION.

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

  MAUDE report 17238470 ↗
• InjuryFeb 13, 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, EMOTIONAL DISTRESS, INFECTION, MENTAL PAIN, INFLAMMATION, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16368764 ↗
• InjuryAug 30, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, ADHESIONS, CHRONIC PAIN, MESH EROSION, MESH MIGRATION, ESOPHAGEAL PERFORATION, SCARRING, AND NUMEROUS PERMANENT LIFE ALTERING COMPLICATIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, FEEDING TUBE, LONGER TERM EXTENDED CARE BY HUSBAND, AND A BLOOD TRANSFUSION.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Anemia; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Chest Pain; Cough; Cramp(s) /Muscle Spasm(s); Depression; Discomfort; Electrolyte Imbalance; Erosion; Fistula; Fluid Discharge; Fungal Infection; Heartburn/Indigestion; Hemorrhage/Blood Loss/Bleeding; Hernia; Hyponatremia; Inflammation; Nausea; Pain; Perforation; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15324267 ↗
• InjuryJul 21, 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 RECURRENCE, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 15075579 ↗
• MalfunctionMar 29, 2022Product Quality Problem; Component Misassembled; Product Quality Problem; Component Misassembled

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL HIATUS HERNIA SURGERY, AFTER OPENING THE PACKAGE, WHEN THE DEVICE WAS CHECKED OUTSIDE THE OPERATION FIELD, THE ADHESION REDUCTION FILM WAS FOUND TO BE ATTACHED TO THE CONTRALATERAL SIDE. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935011 ↗
• MalfunctionMar 8, 2022Product Quality Problem; Component Misassembled; Product Quality Problem; Component Misassembled

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE FILM WAS FOUND TO POSITIONED OPPOSITE. ANOTHER MESH WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690884 ↗
• InjurySep 30, 2021Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Integrity 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 PARAOESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL AND PHYSICAL PAIN, SUFFERING, PHYSICAL DEFORMITY, MESH FAILURE, MENTAL ANGUISH, PERMANENT AND SEVERE SCARRING, DISFIGUREMENT, DEFECTIVE PRODUCT, MESH EROSION, MESH CONTRACTION, INFECTION, ADHESIONS, FISTULA, INFLAMMATION, FOREIGN BODY RESPONSE, SCAR TISSUE, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC AND OTHER ACUTE AND CHRONIC NERVE DAMAGE, PAIN, DYSPHAGIA, VOMITING 3X A WEEK, ENLARGING HERNIA, REFLUX, AND MESH WAS PREVENTING THE RE-APPROXIMATION OF THE CRURA. POST-OPERATIVE PATIENT TREATMENT INCLUDED NISSEN FUNDOPLICATION, CORRECTIVE SURGERY/SURGERIES, ADDITIONAL SURGERY TO REPAIR THE HERNIA THAT THE PARIETEX MESH WAS INITIALLY IMPLANTED TO TREAT, EXCISION OF MESH AND MUSCLE, LYSIS OF ADHESIONS, DIAPHRAGM MUSCLE WAS REMOVED, OPERATIONS TO ATTEMPT TO REPAIR ORGANS, TISSUE, AND NERVE DAMAGE, AND THE USE OF PAIN CONTROL AND OTHER MEDICATIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Dyspareunia; Dysphagia/ Odynophagia; Emotional Changes; Erosion; Failure of Implant; Fistula; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Internal Organ Perforation; Nerve Damage; Neuropathy; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 12558880 ↗
• InjurySep 9, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, RECURRENT HERNIA, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Dysphagia/ Odynophagia; Dyspnea; Hernia; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12448863 ↗
• InjuryAug 13, 2021Adverse 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 TYPE 3 PARAOESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, HERNIA RECURRENCE, AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, HERNIA REPAIR WITH MESH, UMBILICAL HERNIA REPAIRED WITH SUTURES, MESH REMOVAL, DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY, STOMACH REMOVED FROM MESH, TOUPET FUNDOPLICATION, AND REVISION SURGERY.

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

  MAUDE report 12320686 ↗
• InjuryMay 19, 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 ROBOTIC LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCARCERATED PARAESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, PAIN, IMPAIRED TRANSIT OF THE MARSHMALLOW BOLUS ACROSS THE GE JUNCTION WITH STATIS IN DISTAL ESOPHAGUS, GE REFLUX, CHEST/EPIGASTRIC PAIN, DYSPHAGIA, & INDIGESTION/HEARTBURN. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, ESOPHAGRAM, HERNIA REPAIR, ANTERIOR FUNDOPLICATION, HERNIA SAC EXCISED, & ESOPHAGOGASTROSCOPY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Discomfort; Dysphagia/ Odynophagia; Emotional Changes; Heartburn/Indigestion; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11851839 ↗
• InjuryMar 26, 2021Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILED MESH, MIGRATED MESH, EROSION INTO ESOPHAGUS, DIFFICULTY SWALLOWING, AND WEIGHT LOSS. POST-OPERATIVE PATIENT TREATMENT INCLUDED INABILITY TO GO THROUGH REMOVAL SURGERY, FEEDING TUBE, AND PLACED ON SPECIAL DIET.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dysphagia/ Odynophagia; Erosion; Failure of Implant; Pain; Perforation; Stenosis; Unspecified Tissue Injury; Weight Changes

  MAUDE report 11575502 ↗
• InjuryMar 22, 2021Migration 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTION/INFECTED MESH, ABSCESS, FISTULA, SMALL BOWEL PERFORATION, FIBROSIS, LIVERY INJURY, HOARSENESS, REFLUX, REFLUX LARYNGITIS, PAIN, FISTULOUS TRACT, PERFORATION, MESH MIGRATION, FIBROTIC SCAR TISSUE, PURULENT MATERIAL, MESH EROSION, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS, DRAINAGE OF ABSCESS, CLOSURE OF SMALL BOWEL PERFORATION, ESOPHAGOJEJUNOSCOPY, ROUX-EN-Y ESOPHAGOJEJUNOSTOMY, SEGMENTAL SMALL BOWEL RESECTION OF THE ROUX-EN-Y ESOPHAGOJEJUNOSTOMY, AND SEGMENTAL RESECTION OF THE ROUX-EN-Y LOOP CONTAINING THE PERFORATION AND A FISTULA.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Erosion; Fibrosis; Fistula; Obstruction/Occlusion; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11548192 ↗
• InjuryJan 5, 2021Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Integrity 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 HIATAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN/ANGUISH, PHYSICAL PAIN, PERMANENT INJURY, PHYSICAL DEFORMITY, ABDOMINAL PAIN, NAUSEA, CHILLS, LOSS OF APPETITE, WEIGHT LOSS, INFECTION, SCARRING, ADHESIONS, ABSCESS, DISCOMFORT, FAILURE OF MESH, DEFECTIVE MESH, DISFIGUREMENT, MESH EROSION, MESH CONTRACTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC, NERVE DAMAGE, AND LACK OF ENERGY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DRAINAGE OF INFECTION, PAIN MEDICATION, OPERATIONS TO ATTEMPT TO REPAIR ORGANS/TISSUE/NERVE DAMAGE, AND REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Deformity/ Disfigurement; Discomfort; Emotional Changes; Erosion; Failure of Implant; Fatigue; Fistula; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Internal Organ Perforation; Nausea; Nerve Damage; Neuropathy; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 11118692 ↗
• InjuryDec 9, 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 A LUMBAR HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Distress; Hernia; Unspecified Tissue Injury

  MAUDE report 10976799 ↗
• InjurySep 23, 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 A LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HIATAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, DISCOMFORT, STABBING CHEST PAIN WITH SWALLOWING, DYSPHAGIA, ODYNOPHAGIA, WEIGHT LOSS, WATER BRASH, NAUSEA, (&) ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ENDOSCOPY, REPAIR OF HERNIA, REVISION OF NISSEN FUNDOPLICATION, LYSIS OF ADHESIONS, (&) MESH REVISION.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Discomfort; Dysphagia/ Odynophagia; Hernia; Injury; Nausea; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 10576819 ↗
• MalfunctionAug 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC REPAIR OF HIATUS HERNIA, THE MESH WAS PLACED UPSIDE DOWN. THE SURGEON PLACED THE ADHESION REDUCING THE FILM SIDE ON THE DIAPHRAGM SIDE AND PLACED THE MESH SIDE ON THE ORGAN SIDE.

  Patient problems: No Information

  MAUDE report 10355277 ↗
• InjuryJul 14, 2020Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Degraded; 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A PAR AESOPHAGEAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, CALCIFICATION AND HARDENING OF MESH, FOLDING OF MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, HERNIA REPAIR WITH NEW MESH, AND TRIGGER POINT/CORTISONE INJECTIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Calcium Deposits/Calcification; Constipation; Cramp(s) /Muscle Spasm(s); Diarrhea; Hernia; Inflammation; Injury; Nausea; Neuropathy; Pain; Unspecified Tissue Injury

  MAUDE report 10273045 ↗
• InjuryJul 8, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Hernia; Injury; Pain

  MAUDE report 10247413 ↗
• InjuryMay 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, 5 MONTHS POST-OPERATIVE OF A LAPAROSCOPIC HIATAL HERNIA REPAIR WHERE 2 MESHES WERE PLACED, THE PATIENT HAD EMESIS. A MONTH AFTER, GASTROSCOPY WAS PERFORMED AND THE SURGEON SAW A BIG LUMP WHICH CLOSES THE FUNDUS CAUSED BY EROSION OF THE MESH INTO THE FUNDUS. IN TWO WEEKS, THE PATIENT WILL HAVE A THIRD SURGERY WHICH WILL BE TO REMOVE THE MESH BY DOING GASTRECTOMY.

  Patient problems: Hernia; No Code Available; Vomiting

  MAUDE report 10100033 ↗
• InjuryApr 22, 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 LAPAROSCOPIC TREATMENT OF A HIATAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MESH ADHERENT TO LIVER/STOMACH/ESOPHAGUS, RECURRENCE, PAIN, DYSPHAGIA, OBSTRUCTION, AND ANATOMIC TWISTING AND DISTORTION AT THE GASTROESOPHAGEAL JUNCTION FROM THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR; REMOVAL OF MESH SUTURES, AND STAPLES; TAKEDOWN OF PREVIOUS FUNDOPLICATION, LUKE IMPLANTATION, ESOPHAGOGASTROSCOPY; AND FAILED DILATATIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphagia/ Odynophagia; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Tachycardia; Unspecified Tissue Injury

  MAUDE report 9987933 ↗
• InjuryMar 27, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A HIATAL HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SCAR TISSUE, AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, AND REMOVAL OF HIATAL HERNIA MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Discomfort; Erosion; Fluid Discharge; Gastritis; Heartburn/Indigestion; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Pain; Pancreatitis; Scar Tissue; Ulcer; Unspecified Tissue Injury; Urinary Retention; Vomiting

  MAUDE report 9889803 ↗
• InjuryMar 26, 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 A PARA ESOPHAGEAL HIATAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DENSE ADHESIONS, RECURRENCE, GASTRIC REFLUX, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND PARTIAL REMOVAL WITH IMPLANTATION OF SEPRAFILM.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Cramp(s) /Muscle Spasm(s); Diarrhea; Distress; Hernia; Inflammation; Injury; Nausea; No Code Available; Pain; Respiratory Insufficiency; Unspecified Tissue Injury

  MAUDE report 9885580 ↗
• InjurySep 11, 2019Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SHRINKING OF MESH, MIGRATION, RECURRING HERNIA, SEVERE ABDOMINAL PAIN, DIFFICULTY SWALLOWING, REFLUX, WEIGHT LOSS, PHLEGMON OF MESH THAT HAD ROLLED UP INTO A BALL WITH SEVERAL TACKS, AND STOMACH SCARRED. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION AND REMOVAL SURGERY. THE DEVICE HAD BEEN USED WITH UNKNOWN METAL TACKS.

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Inflammation; Injury; No Code Available; Scarring; Weight Changes

  MAUDE report 8987584 ↗
• InjuryJun 11, 2019Material Erosion; Migration or Expulsion of Device; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; Migration or Expulsion of Device; Product Quality 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 HIATAL HERNIA IN A LAPAROSCOPIC REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, GASTRIC FUNDUS DIVERTICULUM, NAUSEA, VOMITING, ADHESIONS, INFLAMMATION, CHRONICALLY ERODED BLACK MESH, INFECTION, MESH MIGRATION AND MESH EROSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, SMALL BOWEL RESECTION AND RECURRENT HIATAL HERNIA REPAIR.

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

  MAUDE report 8687468 ↗
• InjuryApr 8, 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 PARAESOPHAGEAL HERNIA WITH INCARCERATED STOMACH. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED LARGE RECURRENT HERNIA REPAIRED WITH SUTURES, SIGNIFICANT ADHESIONS, STOMACH AND THE LESSER CURVATURE WERE SIGNIFICANTLY ADHERED TO SURROUNDING STRUCTURES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8491230 ↗