Parietex PCO8VP (UDI 10884521514164)Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10884521514164), received between May 9, 2018 and Jul 8, 2026 — classified as 1 death, 68 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (32 reports).

1 other recall cover devices cleared under the same FDA submission (K120506, K142908); they may or may not involve this specific model.

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 90 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PAIN, INFECTION, INFLAMMATION, FISTULA, SEROMA, PERFORATION, MESH EROSION, ABSCESS, CHRONIC DRAINAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC PLACEMENT, MEDICATION, WOUND DEBRIDEMENT, & USE OF BLAKE DRAIN.

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

  MAUDE report 25752730 ↗
• InjuryApr 20, 2026Adverse 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 MESH FAILURE, PAIN, LOSS OF ENJOYMENT OF LIFE, DISABILITY, RECURRENCE, ADHESIONS, INFECTION, INFLAMMATION, SCARRING, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24926372 ↗
• InjuryApr 17, 2026Adverse 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 MESH FAILURE, PAIN, LOSS OF ENJOYMENT OF LIFE, DISABILITY, RECURRENCE, ADHESIONS, INFECTION, INFLAMMATION, SCARRING, NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24913079 ↗
• InjuryApr 7, 2026Adverse 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 RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, PERFORATION, PAIN, ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, REVISION SURGERY.

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

  MAUDE report 24802295 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE INSTALLATION OF THE ANTI-HERNIA MESH, THE PATIENT EXPERIENCED DISCOMFORT, BACKGROUND PAIN, AND REGULARLY VERY INTENSE PAIN. DURING EPISODES OF INTENSE PAIN, THE PATIENT WAS UNABLE TO WALK OR GET UP, ESPECIALLY WHEN THERE WAS A SLIGHT DIFFERENCE IN ALTITUDE. PERMANENT PAIN WAS PRESENT SINCE THE INSTALLATION OF THE ANTI-HERNIA NET, WITH STABBING TYPE PAIN OCCURRING REGULARLY. THE PAIN RESULTED IN AN INABILITY TO PERFORM DAILY ACTIVITIES, JOB LOSS (THE PATIENT HAD TO QUIT THEIR JOB AS A FORESTER DUE TO INABILITY TO WORK), AND THE NEED TO LEAVE A SEASONAL JOB AT TIMES BECAUSE OF PAIN. THE PATIENT CEASED ALL LEISURE ACTIVITIES, INCLUDING HANDBALL, PARAGLIDING, AND HIKING. THE SITUATION CAUSED SIGNIFICANT MENTAL DISTRESS, WITH THE PATIENT FEELING MENTALLY AT THEIR LOWEST AND LIVING VERY BADLY WITH PERMANENT PAIN, AS WELL AS FEELING ABANDONED AND OUT OF BREATH. BLOOD TESTS WERE CONDUCTED SEVERAL TIMES, ALONG WITH ULTRASOUNDS, MAGNETIC RESONANCE IMAGING (MRI), AND COMPUTED TOMOGRAPHY (CT) SCANS. THE PATIENT UNDERWENT PHYSIOTHERAPY SESSIONS AND ATTENDED MULTIPLE APPOINTMENTS WITH SURGEONS AND DOCTORS, BUT WAS REPEATEDLY TOLD THAT NOTHING COULD BE DONE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Pain; Unintended Radiation Exposure

  MAUDE report 24761129 ↗
• 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. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 23457168 ↗
• DeathSep 30, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, ABSCESS, ADHESIONS, OBSTRUCTION, RECURRENCE, FISTULA, INFECTION, PAIN, SUFFERING, EMOTIONAL DISTRESS, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL REMOVAL WITH PRIMARY ANASTOMOSIS, HOSPITALIZATIONS, NG TUBE PLACEMENT, MESH REVISION AND HERNIA REPAIR WITH NEW MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

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

  MAUDE report 23182133 ↗
• InjuryJun 30, 2025Mechanics 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 MESH FAILURE, PAIN, RECURRENCE, ADHESIONS, EMOTIONAL HARM, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MEDICATION, AND LYSIS OF ADHESIONS.

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

  MAUDE report 22365410 ↗
• InjuryJun 10, 2025Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH SHRINKING, MESH CURLING, MESH BUNCHING, MESH TWISTING, MESH SCRUNCHING, PAIN, RECURRENCE, ADHESIONS, AND FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 22178988 ↗
• InjuryFeb 28, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, ADHESIONS, PAIN, BOWEL OBSTRUCTION, DISCOMFORT, DISTRESS, EMOTIONAL HARM, DISFIGUREMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DIAGNOSTIC LAPAROTOMY.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 21494394 ↗
• MalfunctionFeb 12, 2025Component Missing; Material Split, Cut or Torn; Component Missing; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN UMBILICAL HERNIA PROCEDURE WHEN INSERTING THE MESH TO THE PATIENT, THE PHYSICIAN NOTICED CORNER OFF THE MESH WAS DAMAGED AND THE ABSORBABLE COLLAGEN FILM WAS MISSING. TO COMPLETE THE PROCEDURE A NEW MESH WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363468 ↗
• MalfunctionJan 8, 2025Degraded; Degraded

  IT WAS REPORTED THAT PRE-OPERATIVELY FOR AN OPEN UMBILICAL HERNIA PROCEDURE, A MESH VENTRAL PATCH 8CM, WAS FOUND TO BE BRITTLE, JAGGED ALONG THE EDGES AND CRACKED DOWN THE MIDDLE AFTER OPENING THE PACKAGING. THE MESH WAS NEVER IMPLANTED AND A NEW MESH WAS OPENED AND USED IN ITS PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103437 ↗
• MalfunctionJan 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN VENTRAL HERNIA REPAIR PROCEDURE, THE MESH HAD A FISSURE DURING INSERTION INTO PATIENT. A NEW MESH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072221 ↗
• InjuryNov 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, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, SWELLING, DIFFICULTY BENDING DUE TO PAIN, AND STOMACH DEFORMITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, EXPLORATORY LAPAROTOMY AND REPAIR OF RECURRENT HERNIA.

  Patient problems: Abscess; Adhesion(s); Cellulitis; Deformity/ Disfigurement; Fistula; Hernia; Inflammation; Pain; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20674730 ↗
• InjuryOct 1, 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, RECURRENCE, INFLAMMATION, ADHESIONS, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Inflammation; Nerve Damage; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20345888 ↗
• InjuryAug 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ILEUS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, BILATERAL MYOFASCIAL FLAP ROTATION.

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

  MAUDE report 19954877 ↗
• InjuryAug 6, 2024Migration or Expulsion of Device; Mechanics 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, ABDOMINAL PAIN, RECURRENCE, EROSION, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH ANASTOMOSIS, ABDOMINAL SCAR REVISION, WOUND VAC.

  Patient problems: Abdominal Pain; Adhesion(s); Emotional Changes; Erosion; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 19919213 ↗
• InjuryJul 3, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, DRAINAGE, BLEEDING, WOUND INFECTION, HEMATOMA, EDEMA, INDURATION, ERYTHEMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, IV ANTIBIOTICS, OPENING OF WOUND TO ALLOW DRAINAGE, WOUND CARE, ADDITIONAL SURGERY, WOUND DEBRIDEMENT, IRRIGATION OF WOUND, WOUND VAC, INCISION, DRAINAGE, IRRIGATION OF WOUND.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erythema; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19672058 ↗
• MalfunctionJun 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, AFTER AN UMBILICAL HERNIA PROCEDURE, WHEN THE MESH WAS INSERTED INTO THE PATIENT, IT DID NOT STICK. THE MESH HAD TO BE EXPLANTED FROM THE PATIENT TO REPAIR THE RECURRENCE OF THE UMBILICAL HERNIA.

  Patient problems: Hernia

  MAUDE report 19468417 ↗
• InjuryJun 4, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ABSCESS, INFECTION, RECURRENCE, ADHESIONS, SEPSIS, WOUND DEHISCENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, DRAINAGE OF ABDOMINAL ABSCESS.

  Patient problems: Abdominal Distention; Abscess; Adhesion(s); Burning Sensation; Emotional Changes; Hernia; Pain; Scar Tissue; Sepsis; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19462670 ↗
• InjuryApr 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, ONE YEAR POSTOPERATIVE TO AN OPEN UMBILICAL HERNIA REPAIR, AN ADDITIONAL OPERATION WAS PERFORMED DUE TO THE MESH DID NOT ADHERE AND HAD TO BE EXPLANTED FROM THE PATIENT TO REPAIR THE HERNIA. IT WAS NOTED THAT THERE WAS PAIN AND PROTRUSION OF THE HERNIAL SAC. ANOTHER MESH WAS PLACED USING IPOM (INTRAPERITONEAL ONLAY MESH) TECHNIQUE TO RESOLVE THE ISSUE.

  Patient problems: Pain; Tissue Breakdown

  MAUDE report 19149710 ↗
• InjuryApr 2, 2024Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; 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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, MESH MIGRATION, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, TAKEDOWN OF ADHESIONS.

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

  MAUDE report 19021138 ↗
• InjuryApr 1, 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, DISABILITY, BULKY AND HARD BUMP BY STOMACH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 19016309 ↗
• InjuryMar 29, 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; 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, DEFECTIVE MESH, FAILURE OF MESH, ABSCESS, INFECTION, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, DRAINAGE OF ABSCESS.

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

  MAUDE report 19005812 ↗
• InjuryMar 26, 2024Mechanics 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 INCISIONAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, ADHESIONS, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS.

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

  MAUDE report 18980644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120506, K142908. One submission often covers many models, so check the product and lot details in each record.

• Z-0461-2019 · Oct 5, 2018 · Terminated
  Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional mon