Symbotex SYM3728Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521190566), received between Sep 15, 2017 and Aug 8, 2025 — classified as 1 death, 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (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 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Emotional Changes; Hernia; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22751846 ↗
• InjuryJan 22, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, DRAIN PLACED.

  Patient problems: Abdominal Pain; Discomfort; Emotional Changes; Hernia; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 18554725 ↗
• InjuryNov 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, TAKE DOWN OF INCARCERATED BOWEL.

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

  MAUDE report 18123589 ↗
• InjuryNov 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 18121976 ↗
• InjuryOct 27, 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 FAILURE OF MESH, DEFECTIVE MESH, RECURRENCE, ADHESIONS, ABDOMINAL PAIN, DISCOMFORT, DISFIGUREMENT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, PRIMARY HERNIA REPAIR WITH COMPONENT SEPARATION.

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

  MAUDE report 18023292 ↗
• InjuryJun 19, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, RECURRENCE, ADHESIONS, ABSCESS, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, REMOVAL OF ADHESIONS.

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

  MAUDE report 17156428 ↗
• InjuryMar 2, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Mechanics Altered; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, RECURRENCE, SCARRING, INFLAMMATION, INFECTION, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 16467446 ↗
• InjuryFeb 8, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Mechanics Altered; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SUFFERING, LARGE MID ABDOMINAL SEROMA CONTAINING 900 ML OF FLUID, SEPARATION OR LITTLE TEAR IN MESH, DEFECTIVE DEVICE, PAIN, MENTAL PAIN, ABDOMINAL PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, SCARRING, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR, DRAINAGE OF SEROMA AND SURGICAL DISSECTION.

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

  MAUDE report 16321772 ↗
• InjuryAug 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFECTION, INFLAMMATION, ADHESIONS, AND ABSCESS. P OST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, JP DRAIN, AND MESH REVISION.

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

  MAUDE report 15324327 ↗
• InjuryJun 16, 2022Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFLAMMATION, MESH MIGRATION, ADHESIONS, DEFECTIVE DEVICE, MESH FAILURE, SCARRING, MENTAL PAIN, SUFFERING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Distress; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14716682 ↗
• InjuryApr 8, 2021Adverse 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FRACTURE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11636370 ↗
• InjuryFeb 19, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC, DEBRIDEMENT, AND MESH REMOVAL.

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

  MAUDE report 11348570 ↗
• InjuryJan 5, 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 HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED SEROMA, INFECTION, ABDOMINAL PAIN, INFLAMMATION, ABSCESS, AND FLUID COLLECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED DRAINAGE OF FLUID COLLECTION AND REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Abscess; Ascites; Inflammation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11116451 ↗
• InjuryNov 18, 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 10860144 ↗
• InjurySep 22, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Mechanics Altered; 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, PAIN, DISCOMFORT, INFLAMMATION, COMPLETE FRACTURING OF MESH, ADHESIONS, RECURRENCE, AND MESH SEPARATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, REMOVAL OF MESH, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Constipation; Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Injury; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 10565368 ↗
• InjurySep 18, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HEMATOMA, OBSTRUCTION, BLEEDING, MOBILITY ISSUES, BALANCE ISSUES, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, PAIN, DISCOMFORT, INFLAMMATION, OPEN DRAINING WOUND, MESH PULLED AWAY, MESH DETACHMENT, WOUND DEHISCENCE, RECURRENCE, ADHESIONS, PORTION OF SMALL BOWEL PROTRUDING THROUGH SKIN, ASCITES, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, MESH REMOVAL, ADMISSION TO HOSPITAL, EXPLORATORY LAPAROTOMY, AND LYSIS OF ADHESIONS. CONCOMITANT DEVICE: UNKNOWN VICRYL MESH TACKER.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Balance Problems; Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Incontinence; Inflammation; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10554782 ↗
• InjuryJul 17, 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABSCESS, SWELLING, REDNESS, PURULENT MATERIAL, EXPOSED MESH, AND ABUNDANT EPITHELIALIZATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, INCISION/DRAINAGE OF ABSCESS, PARTIAL REMOVAL OF MESH, WOUND DRESSINGS, ABUNDANT EPITHELIALIZATION REMOVED, AND ADMISSION TO HOSPITAL.

  Patient problems: Abscess; Injury; No Code Available; Purulent Discharge; Swelling

  MAUDE report 10292153 ↗
• InjuryMay 28, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 10097092 ↗
• InjuryOct 22, 2019Adverse 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

  ACCORDING TO THE REPORTER, THE PATIENT WAS DIAGNOSED BY ULTRASOUND TO HAD AN INTESTINAL TORMENT AND ABDOMINAL PAIN FOLLOWING AN ENTERORRHAPHY WITH MESH PLACEMENT PROCEDURE. ULTRASOUND IMAGES WERE REVIEWED AND LOOSE MESH IN MEDIAN LINE WITH PROTRUDING HANDLES WERE OBSERVED. AFTER THAT, THE PATIENT WAS SET FOR SURGICAL REINTERVENTION AND PERFORM INCISIONAL HERNIORRHAPHY WITH MESH PLACEMENT, BY EVISCERATION BY DETACHMENT OF MESH IN LOWER MARGIN. THERE WAS TEAR IN THE MESH FIXATION POINTS AND THE HANDLES WERE DILATED AND DISPLACED OUTSIDE THE CAVITY. THERE WAS ALSO JEJUNUM OBSTRUCTION AND OMENTAL ADHESION ON THE SIGMOID COLON. IT WAS STATED THAT AN X-RAY WAS PERFORMED TO LOCATE THE MESH INSIDE THE PATIENT. THE EVENT RESULTED TO TISSUE DAMAGE AND BLOOD LOSS OF 500CC. IT WAS ALSO STATED THAT THERE WAS AN INCISION EXTENSION TO MORE THAN 1 INCH AND SURGICAL TIME EXTENSION TO 30 MINUTES OR MORE. THE PATIENT HAD TO BE INCLUDED IN INTENSIVE CARE UNIT RESULTING TO PATIENT¿S EXTENDED HOSPITALIZATION. A LAPAROTOMY, TORSION CORRECTION AND THE MESH WAS STITCHED AGAIN TO RESOLVE THE ISSUE. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Abdominal Pain; Adhesion(s); Blood Loss; No Code Available; Obstruction/Occlusion; Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 9222033 ↗
• InjurySep 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 8954041 ↗
• InjuryJul 10, 2019Material Perforation; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Perforation; 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, LARGE AMOUNT OF FLUID AND AIR, SMALL BOWEL PERFORATIONS, FOUL-SMELLING CLOUDY FLUID, PERITONITIS, AND MULTIPLE ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC EXPLORATION DUE TO PAIN, SMALL BOWEL RESECTION WITH ANASTOMOSIS, ASPIRATION OF FOUL-SMELLING CLOUDY FLUID AS WELL AS REMOVAL OF OLD MESH. THE DEVICE WAS USED WITH AN UNKNOWN ABSORBABLE TACKER.

  Patient problems: Adhesion(s); Ascites; Bowel Perforation; Discharge; Injury; Pain; Peritonitis; Purulent Discharge

  MAUDE report 8778423 ↗
• InjuryMar 27, 2019Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SCARRING, PAIN, DISCOMFORT, SEROSANGUINOUS FLUID, EDEMA, INFECTION, ABSCESS, SEROMA, INFLAMMATION, OPEN DRAINING WOUND, ADHESIONS TO BOWEL, HERNIA RECURRENCE, CHRONIC ABDOMINAL PAIN AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Discomfort; Edema; Emotional Changes; Fluid Discharge; Hematoma; Hernia; Impaired Healing; Inflammation; Injury; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8456407 ↗
• InjuryMay 30, 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. IT WAS REPORTED THAT AFTER A HERNIA PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED MULTIPLE SURGICAL REVISIONS, LARGE FLUCTUATING MASS UNDERNEATH SURGICAL INCISION CONSISTENT WITH POSTOPERATIVE SEROMA, INCISION AND DRAINAGE, ASPIRATION, LEFT FLANK HERNIA RECURRENCE, OPEN LEFT MYOFASCIAL ADVANCEMENT FLAP, REMOVAL OF PARIETEX MESH IN ITS ENTIRETY, LYSIS OF ADHESIONS, SIGMOID AND COLON ADHERED TO SYMBOTEX MESH. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Discharge; Distress; Hemorrhage/Blood Loss/Bleeding; Hernia; Injury; Muscle Weakness/Atrophy; No Code Available; Numbness; Pain; Seroma; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Weakness

  MAUDE report 7555277 ↗
• DeathJan 25, 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 RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, EXTENSIVE ADHESIOLYSIS, REMOVAL OF OLD MESH AND REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. HIS ORIGINAL SURGERY WAS 11 MONTHS AGO. THE PATIENT EXPERIENCED PAIN, ADHESIONS, AND HERNIA RECURRENCE.

  Patient problems: Adhesion(s); Fistula; Hernia; Injury; No Code Available; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection

  MAUDE report 7220018 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Torn Material; Adverse Event Without Identified Device or Use Problem; Torn Material

  ACCORDING THE REPORTER: THE PATIENT UNDERWENT A LAPAROSCOPIC RECURRENT INCISIONAL VENTRAL HERNIA REPAIR. FOUR DAYS POST OP, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO REMOVE THE GRAFT WHICH LEAD TO EXTENDED HOSPITALIZATION AND CAUSED TEMPORARY INJURY TO THE PATIENT. THE SURGEON DESCRIBED THE MESH AS "FAULTY." THE CURRENT PATIENT STATUS IS INPATIENT ICU. AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 6873655 ↗