Symbotex SYM2012ERecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521190436), received between Jun 23, 2017 and May 6, 2025 — classified as 26 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING ROBOTIC LAPAROSCOPIC PROCEDURES FOR INCISIONAL HERNIA REPAIRS, THE BARRIER ON THE MESH BEGAN COMING OFF ONCE INTRODUCED INTO THE PATIENT'S ABDOMEN, ALTHOUGH THE MESH WAS STILL USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968749 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC PROCEDURES FOR VENTRAL/INCISIONAL HERNIA REPAIRS, THE BARRIER ON THE MESH BEGAN COMING OFF ONCE INTRODUCED INTO THE PATIENT'S ABDOMEN, ALTHOUGH THE MESH WAS STILL USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937528 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC PROCEDURES FOR VENTRAL/INCISIONAL HERNIA REPAIRS, THE BARRIER ON THE MESH BEGAN COMING OFF ONCE INTRODUCED INTO THE PATIENT'S ABDOMEN, ALTHOUGH THE MESH WAS STILL USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937508 ↗
• InjuryJan 22, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION, INFLAMMATION, INFECTION, NERVE DAMAGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, LYSIS OF ADHESIONS.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nerve Damage; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Gastrointestinal Problem; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18555668 ↗
• InjuryJun 1, 2023Material 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, RECURRENCE, ADHESIONS, SEROMA, BOWEL OBSTRUCTION, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 17039494 ↗
• InjuryApr 28, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, MESH MIGRATION, DEFECTIVE MESH, PAIN, DISFIGUREMENT, ADHESIONS, ABDOMINAL PAIN, DISCOMFORT, RECURRENCE, MENTAL PAIN, SCARRING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, ADHESIOLYSIS.

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

  MAUDE report 16833623 ↗
• InjuryMar 9, 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, SEROMA, ADHESIONS, PAIN, INFLAMMATION, MENTAL PAIN, SCARRING, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 16513286 ↗
• InjuryJan 12, 2023Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SORE ABDOMEN, MESH MIGRATION, INCARCERATED HERNIA, ABDOMINAL PAIN, PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 16149230 ↗
• InjuryNov 22, 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, PAIN, INFLAMMATION, MENTAL PAIN, SCARRING, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, BLEEDING, AND HEMATOMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADHESIOLYSIS, EXPLANTATION OF MESH, AND HERNIA REPAIR WITH MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Discomfort; Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15841140 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH SURGERY FOR HERNIA, PATIENT HAD PAIN WHILE SITTING AND STANDING. SITUATION WAS GETTING BETTER WHEN PATIENT WAS LYING.

  Patient problems: Pain

  MAUDE report 15042080 ↗
• InjuryJul 29, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEROMA, ABSCESS, INFECTION, MESH MIGRATION, MESH EROSION, FISTULA, OPEN WOUND, MIXED BACTERIA FLORA, ENTEROCOCCUS FAECALIS, FULL THICKNESS INJURY TO COLON, DRAINING ABDOMINAL WOUND, INDURATION, INFECTED MESH, ADHESIONS, PERFORATION, INFLAMMATION, WOUND DEBRIDEMENT, AND BACTERIAL INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, REMOVAL OF MESH, WOUND VAC, REPAIR OF COLOTOMY, DRAINAGE OF ABDOMINAL WOUND ABSCESS, HERNIA SAC RESECTED, HERNIA REPAIR WITH NEW MESH, WOUND DEBRIDEMENT, FRENCH AND BLAKE DRAIN USE, AND MEDICATION. CONCOMITANT DEVICE: SECURESTRAP ABSORBABLE FIXATION DEVICE (PRODUCT ID: STRAP25, LOT NUMBER: PL5536) RELEVANT TESTS/LABORATORY DATA: (B)(6) 2020: WOUND CULTURE + FOR MANY WHITE BLOOD CELLS, MIXED BACTERIA FLORA, ENTEROCOCCUS FAECALIS

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Erosion; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12247586 ↗
• InjuryJul 20, 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

  ACCORDING TO THE REPORTER, TWO YEARS AFTER A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR IN THE ABDOMEN, THE PATIENT WAS TAKEN BACK TO SURGERY WHERE THE SURGEON DISCOVERED THAT THE MESH INCORPORATED VERY WELL EXCEPT IN THE CENTER WHERE IT WAS TORN OR RIPPED. TO RESOLVE THE ISSUE, A DIFFERENT MESH WAS USED. THE SURGERY GOT EXTENDED FOR MORE THAN 30 MINUTES AND THE PATIENT HAD TO BE HOSPITALIZED FOR ONE TO TWO DAYS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12196755 ↗
• InjuryJul 2, 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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, RECURRENCE, ABDOMINAL PAIN, CONSTIPATION, BLEEDING, SIGNIFICANT BUCKING EPISODE, AND BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, IV FLUIDS, NASOGASTRIC SUCTION, SIGNIFICANT RELEASE OF INCARCERATED SMALL BOWEL, ENTEROLYSIS, SAC REMOVED, ADMISSION TO HOSPITAL, MESH EXCISED, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Deformity/ Disfigurement; Depression; Emotional Changes; Hemorrhage/Blood Loss/Bleeding; Hernia; Obstruction/Occlusion; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12109233 ↗
• 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE UNDERLAY IMPLANT, THE PATIENT EXPERIENCED HEMATOMA, ABSCESS, INFECTION, WOUND-HEALING ISSUES, NAUSEA, CHILLS, INFLAMMATION, LOSS OF APPETITE, CHRONIC PAIN, EXTREME WEIGHT LOSS, DIARRHEA, SEROMA, ABDOMINAL PAIN, DRAINAGE, ADHESIONS, FAILURE OF MESH, SCARRING, MENTAL PAIN/ANGUISH, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION TO HOSPITAL, EVACUATION OF HEMATOMA, NEGATIVE PRESSURE WOUND THERAPY, WOUND VAC, HOSPITALIZATION, INCISION/DRAINAGE OF ABSCESS, ANTIBIOTICS, IR DRAIN PLACED, MESH REMOVAL, MESH INTERVENTION SURGERY, AND NEED FOR FUTURE MEDICAL TREATMENT.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Chills; Decreased Appetite; Diarrhea; Emotional Changes; Fluid Discharge; Hematoma; Impaired Healing; Inflammation; Nausea; Pain; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury; Weight Changes

  MAUDE report 12025063 ↗
• InjuryNov 24, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED BOWEL OBSTRUCTION/PROBLEMS, INFECTION, PAIN, INFLAMMATION, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TWO PARTIAL MESH REMOVALS, AND BOWEL RESECTION.

  Patient problems: Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10897762 ↗
• InjuryOct 27, 2020Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, ABDOMINAL PAIN, PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, MESH MIGRATION, FAILURE OF MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH INTERVENTION SURGERY, AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10741615 ↗
• InjurySep 21, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, CHRONIC PAIN, AND REACTIVE CHANGES TO TISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Hernia; Injury; No Code Available; Pain

  MAUDE report 10564079 ↗
• InjuryAug 14, 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 TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, AND DENSE ADHESIONS OF SMALL BOWEL TO MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, AND MESH REMOVAL.

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

  MAUDE report 10410496 ↗
• InjuryJul 8, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, PAIN, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Diarrhea; Discomfort; Emotional Changes; Hematoma; Hernia; Inflammation; Injury; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10244678 ↗
• InjuryApr 6, 2020Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CONTRACTED MESH, RECURRENCE, ADHESIONS, CHOLETHIASIS, AND ILEUS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, BILATERAL COMPONENT SEPARATION, EXCISION OF MESH, CHOLECYSTECTOMY, AND IV FLUIDS.

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

  MAUDE report 9929281 ↗
• InjuryDec 13, 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 OVERLAY IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE AND DISTAL TRANSVERSE COLON WITH INFLAMMATORY MASS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS AND REMOVAL SURGERY.

  Patient problems: Adhesion(s); Hernia; Inflammation; Injury; No Code Available

  MAUDE report 9465034 ↗
• InjuryOct 29, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN DUE TO FAILURE OF THE MESH AND ADHESIONS.. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 9251133 ↗
• InjuryJul 17, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN IN CARCERATED VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Injury

  MAUDE report 8800775 ↗
• InjuryJun 11, 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

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SMALL BOWEL OBSTRUCTION, OBSTIPATION, ABDOMINAL PAIN, NAUSEA AND VOMITING, AND PREVIOUS MESH WAS CUT THROUGH. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Hernia; Inflammation; Injury; Nausea; Obstruction/Occlusion; Pain; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 8688129 ↗
• InjuryMar 29, 2019Migration 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 INCARCERATED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, ADHESIONS, FRACTURED AND RETRACTED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED PLACEMENT OF NEW MESH, SMALL BOWEL ADHERENT TO MESH AND DISSECTION OF OMENTUM AND LYSIS OF ADHESIONS. (B)(6) 2017 - HERNIA RECURRENCE REQUIRING PLACEMENT OF NEW BARD VENTRALIGHT ST MESH.

  Patient problems: Adhesion(s); Hernia; Injury; No Code Available

  MAUDE report 8465300 ↗