Parietex PCO1510OSXRecalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10884521179691), received between Sep 12, 2017 and Oct 1, 2025 — classified as 2 deaths, 106 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (36 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23196679 ↗
• InjuryJun 10, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, SEROSAL INJURY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH.

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

  MAUDE report 19502744 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 19193588 ↗
• InjuryOct 31, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN, AND MESH EXPULSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, AND MESH REVISION.

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

  MAUDE report 18043613 ↗
• InjuryJun 22, 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, ADHESIONS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REVISION OF MESH.

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

  MAUDE report 17183147 ↗
• InjuryFeb 7, 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 IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ADHESIONS, PAIN, AND SEROSAL TEAR. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Anxiety; Deformity/ Disfigurement; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 16315514 ↗
• InjuryJan 5, 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 RECURRENCE, ADHESIONS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, SMALL BOWEL RESECTION, REVISION SURGERY.

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

  MAUDE report 16103327 ↗
• InjuryJan 5, 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 RECURRENCE, ADHESIONS, <(>&<)> CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, SMALL BOWEL RESECTION, <(>&<)> REVISION SURGERY.

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

  MAUDE report 16103290 ↗
• InjuryOct 11, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, ADHESIONS, DETACHMENT, SHRINKAGE OF MESH, EROSION, OBSTRUCTION, RECURRENCE, SHRINKAGE AND DISENGAGEMENT OF MESH FROM THE INFERIOR AND LATERAL EDGE OF THE HERNIA TO THE RIGHT. POST-OPERATIVE PATIENT TREATMENT INCLUDED USAGE OF DRAIN, REMOVAL OF MESH, MEDICATIONS, AND SMALL BOWEL RESECTION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Electrolyte Imbalance; Erosion; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 15577649 ↗
• InjuryAug 31, 2022Adverse 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, SCARIFICATION, MESH ENCAPSULATION, INABILITY TO DO ACTIVITIES, NAUSEA, AND LACK OF ADEQUATE INGROWTH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15330791 ↗
• InjuryJul 25, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, OBSTRUCTION, AND CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED SMALL BOWEL RESECTION.

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

  MAUDE report 15099825 ↗
• InjuryMay 3, 2022Migration 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, INFECTION, ABSCESS, PAIN AND MESH WAS BUNCHED UP IN SEVERAL PLACES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Constipation; Discomfort; Erythema; Fever; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 14269204 ↗
• InjuryApr 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MENTAL PAIN, PAIN, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Abscess; Emotional Changes; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14247033 ↗
• InjurySep 30, 2021Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Integrity Problem; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, PAIN/SUFFERING, PHYSICAL DEFORMITY, DEVICE DEFECTIVE, IMPLANT FAILURE, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, MESH CONTRACTION, ADHESION FISTULA, INFLAMMATION, FOREIGN BODY RESPONSE, SCAR TISSUE, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC, NERVE DAMAGE, ABDOMINAL PAIN, INFECTION, ADHESIONS, ENTEROCUTANEOUS FISTULA, EROSION OF SMALL BOWEL INTO UNDERLAY OF MESH, ABDOMINAL WALL ABSCESS, UMBILICAL DISCOMFORT AND SWELLING. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, MESH REMOVAL AND SHARP EXCISION 20 CM OF SKIN AND SUBCUTANEOUS TISSUE, ATTEMPT TO REPAIR ORGANS, TISSUE, AND NERVE DAMAGE, ENTEROCUTANEOUS FISTULA TAKEDOWN, USE OF PAIN CONTROL AND OTHER MEDICATIONS.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Cancer; Cellulitis; Deformity/ Disfigurement; Diarrhea; Discomfort; Dyspareunia; Electrolyte Imbalance; Emotional Changes; Erosion; Erythema; Failure of Implant; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Internal Organ Perforation; Muscle Weakness/Atrophy; Necrosis; Nerve Damage; Neuropathy; Obstruction/Occlusion; Pain; Purulent Discharge; Renal Failure; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12558837 ↗
• InjurySep 2, 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 THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, SCAR TISSUE, ATTENUATED FASCIA, ADHESIONS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, COMPONENT SEPARATION, BILATERAL TRANSVERSUS ABDOMINUS PLANE BLOCK, ABDOMINAL VAC, DRAIN USAGE, NEGATIVE PRESSURE WOUND THERAPY, USE OF ABDOMINAL BINDER, REVISION SURGERY, MESH REMOVAL, AND HERNIA REPAIR WITH MESH.

  Patient problems: Adhesion(s); Discomfort; Hernia; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 12418987 ↗
• InjuryAug 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SEROMA, PERMANENT PHYSICAL EMOTIONAL HARM, FAILURE OF MESH, OPEN WOUND, DISCOMFORT, RECURRENCE, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, EXPLORATORY LAPAROTOMY, DEBRIDEMENT, INCISION AND DRAINAGE, MESH REMOVAL, MEDICATION, AND HOME HEALTH CARE.

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

  MAUDE report 12343006 ↗
• InjuryAug 13, 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 A VENTRAL HERNIA AND RIGHT/LEFT INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, SEGMENTAL PULMONARY EMBOLI, ATELECTASIS, SLOWLY IMPROVING TACHYCARDIA, DIARRHEA, RECURRENCE, OLIGURIA [ABNORMALLY SMALL AMOUNTS OF URINE], PAIN, NAUSEA, VOMITING, FEVER, CHILLS, SMALL BOWEL OBSTRUCTION, ABDOMINAL PAIN, SEROSAL TRACTION TEAR, PULMONARY INFARCTS, INFLAMMATION, AIR-FLUID COLLECTION, AND ILEUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PICC LINE PLACED, NG TUBE, THERAPEUTIC ANTICOAGULATION FOR PE, IV HYDRATION, ANALGESICS, HERNIA REPAIR WITH NEW MESH, ADMISSION TO HOSPITAL, LYSIS OF ADHESIONS, SEROSAL TRACTION TEAR REPAIRED, DRAIN IN PLACE, AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chills; Diarrhea; Distress; Fever; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Pulmonary Embolism; Pulmonary Infarction; Tachycardia; Unspecified Infection; Unspecified Tissue Injury; Urinary Retention; Vomiting

  MAUDE report 12320925 ↗
• InjuryAug 5, 2021Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, LOSS OF ENJOYMENT OF LIFE, INFECTION, INJURIES, DAMAGES, DEFECTIVE MESH, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HOSPITALIZATION, DIAGNOSTIC IMAGING, REVISION SURGERY, SERUM TESTING, ANTIBIOTICS AND ANALGESICS.

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

  MAUDE report 12281202 ↗
• InjuryJul 29, 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, MESH FAILURE, EMOTIONAL HARM, DISCOMFORT, ADHESIONS, PAIN, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, HERNIA REPAIR WITH NEW MESH, ADHESIOLYSIS, ADDITIONAL SURGERY AND MESH REMOVAL.

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

  MAUDE report 12246006 ↗
• InjuryJun 18, 2021Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Material Deformation; 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 RIGHT FLANK INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, FISTULA, FAILURE OF MESH, INFLAMMATION, CHRONIC PAIN AND CHRONIC TISSUE GRANULATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Discomfort; Failure of Implant; Fistula; Hematoma; Hernia; Inflammation; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12029258 ↗
• InjuryJun 18, 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 THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, PAIN, AND MESH EXPOSURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL SURGERY, AND MESH REMOVAL.

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

  MAUDE report 12026226 ↗
• InjuryJun 18, 2021Migration 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 A PARASTOMAL HERNIA AND AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED WOUND WITH MESH EXTRUDING, WHITE MATERIAL COMING FROM THE ABDOMEN, INFECTION, PAIN, OPEN NON-HEALING WOUND, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, WOUND PACKED WITH GAUZE, AND REVISION SURGERY.

  Patient problems: Impaired Healing; Inflammation; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12025794 ↗
• InjuryApr 23, 2021Migration 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED MESH PULLED AWAY, RECURRENCE, MESH FOLDED ON ITSELF, ADHESIONS, NEURALGIA PAIN, TENDERNESS, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11717139 ↗
• InjuryMar 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 THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, ALL ASPECTS OF LIFE NEGATIVELY IMPACTED, EMOTIONAL HARM, MESH FAILURE, ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, LYSIS OF ADHESIONS AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11528154 ↗
• InjuryFeb 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 THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, NUMBNESS, PULLING SENSATION, NAUSEA, DIARRHEA, CHILLS, LOSS OF APPETITE, INFLAMMATION, BODY DISFIGUREMENT, PAIN, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Decreased Appetite; Deformity/ Disfigurement; Diarrhea; Discomfort; Emotional Changes; Hernia; Inflammation; Nausea; Numbness; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11349313 ↗