Symbotex SYM2520OSRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521190504), received between Sep 15, 2017 and Nov 11, 2024 — classified as 19 injuries, 1 malfunction.

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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Migration 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MESH MIGRATION, DISCOMFORT, INFLAMMATION, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 20657409 ↗
• InjuryMay 10, 2024Material 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, PERFORATION, INFECTION, PURULENT DISCHARGE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, REPAIR OF PERFORATION, PLACEMENT OF DRAIN.

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

  MAUDE report 19292426 ↗
• InjurySep 15, 2022Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; 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 RECURRENCE, PAIN, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MESH DENSELY ADHERENT TO THE BLADDER, DEFECTIVE DEVICE, MESH FAILURE, AND MESH BALLOONED OUT INTO THE HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND REMOVAL OF MESH.

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

  MAUDE report 15428863 ↗
• InjurySep 7, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, SUFFERING, EMOTIONAL DISTRESS, DIMINISHED QUALITY OF LIFE, MENTAL PAIN, DEVICE DEFECTIVE, ADHESIONS, CHRONIC INFLAMMATORY RESPONSE, BOWEL PROBLEMS, INFECTIONS, MENTAL ANGUISH, DISABILITY, IMPAIRMENT, & LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, MESH REMOVAL, WOUND CLOSURE, & REPAIR OF MESH.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Distress; Electrolyte Imbalance; Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Low Blood Pressure/ Hypotension; Nausea; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15375505 ↗
• InjuryJul 29, 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 THE IMPLANT, THE PATIENT EXPERIENCED OPEN DRAINING ABDOMINAL WOUND, INFECTION, PURULENT MATERIAL, INFLAMMATION, ABSCESS, FLUID COLLECTION, (B)(6), ABDOMINAL PAIN, NAUSEA, VOMITING, SWEATS AT NIGHT, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED DEBRIDEMENT, REMOVAL OF MESH, INFLAMED TISSUE REMOVED, ABSCESS DRAINED, CATHETER PLACED, WOUND VAC, ADMISSION TO HOSPITAL, ANTIBIOTICS, CATHETER PLACEMENT, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Abscess; Ascites; Bacterial Infection; Diaphoresis; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Nausea; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 12245995 ↗
• InjuryMay 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION PROBLEMS, AND HERNIA RECURRENCE. POST-OPERATIVE TREATMENT INCLUDED ADDITIONAL SURGERY, REVISION SURGERY, AND MESH REMOVAL.

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

  MAUDE report 11852116 ↗
• InjuryMay 14, 2021Degraded; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED VENTRAL HERNIA RECURRENCE, INCARCERATED HERNIA, MESH MIGRATION, FOLDED MESH, ADHESIONS, SMALL BOWEL OBSTRUCTION, FISTULA, INFECTION, ABSCESS, DRAINAGE, DRAINING SINUS TRACT, FLUID COLLECTION, FOREIGN BODY GIANT CELL REACTION, ABDOMINAL PAIN, SEROMA, FEVER, INFLAMMATION, BLOATING, CRAMPING, NAUSEA, DRY HEAVES, CHILLS, DIARRHEA, LOSS OF APPETITE, RASH, DISTENDED SMALL BOWEL LOOPS, AND PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH EXPLANT, MULTIPLE RECURRENT VENTRAL HERNIA REPAIRS WITH IMPLANT OF NEW MESH, LYSIS OF ADHESIONS, EXCISION OF DRAINING SINUS TRACT, TPN, ADMISSION TO HOSPITAL, EVACUATION OF PURULENT FLUID COLLECTION, CT SCAN, WOUND VAC, POCKET OF INFLAMMATORY CHANGE OPENED UP AND LAVAGED, MEDICATION, PICC LINE, PCA PUMP, AND FISTULA REPAIR.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Chills; Cramp(s) /Muscle Spasm(s); Decreased Appetite; Diarrhea; Erosion; Fever; Fistula; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Nausea; Obstruction/Occlusion; Pain; Purulent Discharge; Rash; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11825202 ↗
• InjuryApr 8, 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 FLANK HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 11635997 ↗
• InjurySep 29, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, SEROMA, ADHESIONS, BOWEL INVOLVEMENT, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Nausea; No Code Available; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Seroma; Tachycardia; Unspecified Tissue Injury; Vomiting

  MAUDE report 10603367 ↗
• 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 VENTRAL 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 10247633 ↗
• InjuryApr 3, 2020Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; 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 THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, INFECTION, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH EXCISION.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Constipation; Emotional Changes; Fatigue; Fibrosis; Fistula; Fluid Discharge; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; Nausea; Necrosis; Obstruction/Occlusion; Pain; Partial Hearing Loss; Perforation; Purulent Discharge; Scar Tissue; Seroma; Swelling/ Edema; Tachycardia; Unspecified Infection; Unspecified Musculoskeletal problem; Unspecified Tissue Injury; Visual Impairment; Vomiting

  MAUDE report 9920678 ↗
• InjuryJan 30, 2020Migration 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 OPEN THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA AS WELL AS BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INCARCERATED INGUINAL HERNIA, ADHESIVE DISEASE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, RECURRENCE, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, SMALL BOWEL RESECTION, HERNIA REPAIR WITH NEW MESH, ANALYSIS OF ADHESIONS.

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

  MAUDE report 9649590 ↗
• InjuryJan 28, 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 OPEN THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA AS WELL AS BILATERAL INGUINAL HERNIAS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INCARCERATED INGUINAL HERNIA, ADHESIVE DISEASE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, RECURRENCE, ADHESIONS, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, SMALL BOWEL RESECTION, HERNIA REPAIR WITH NEW MESH, ANALYSIS OF ADHESIONS.

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

  MAUDE report 9639776 ↗
• InjuryJul 5, 2019Material Erosion; Migration or Expulsion of Device; Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Erosion; Migration or Expulsion of Device; Detachment of Device or Device Component; 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 SYMPTOMATIC VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA DRAINAGE, PAIN, RECURRENCE, ABSCESS, MESH MIGRATION, OPEN WOUND, ADHESIONS, RESIDUAL POCKET SEROMA, MESH EROSION INTO BOTH SIDES OF ABDOMINAL CAVITY, RECURRENT SMALL BOWEL OBSTRUCTION, SEROSAL TEARS, CHRONIC ABDOMINAL PAIN, CHRONIC DEPRESSION, AND SMALL BOWEL LESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISION OF MESH DUE TO PAIN, REPAIR OF RESULTANT VENTRAL INCISIONAL HERNIA WITH NEW MESH, LYSIS OF MULTIPLE DENSE ADHESIONS, EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS, INJECTION DUE TO CHRONIC ABDOMINAL PAIN, LARGE COMPLEX INCARCERATED INCISIONAL HERNIA RECURRENCE REQUIRING PLACEMENT OF NEW MESH, SMALL BOWEL LESIONS REPAIRED, CHOLECYSTECTOMY, WOUND VAC, AS WELL AS EXCISION OF MESH FRAGMENTS.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Corneal Pannus; Depression; Discharge; Discomfort; Emotional Changes; Erosion; Excessive Tear Production; Fibrosis; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Injury; Ischemia; Laceration(s); Localized Skin Lesion; Nausea; No Code Available; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Seroma; Unspecified Tissue Injury; Vomiting

  MAUDE report 8765386 ↗
• InjuryApr 17, 2019Loss of or Failure to Bond; Material Erosion; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Material Erosion; 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 AN INCARCERATED INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED NON-HEALING WOUND, PARTIAL DEHISCENCE AT INFERIOR, AMPLE SLACK IN MESH WHICH WAS NOT ADHERENT TO THE BOWEL, MESH FOLDED OVER, ADHESIONS, SURGICAL WOUND OF THE ABDOMINAL WALL WITH EXPOSED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, WOUND VAC PLACEMENT, LYSIS OF ADHESIONS.

  Patient problems: Adhesion(s); Erosion; Impaired Healing; Injury; Wound Dehiscence

  MAUDE report 8523525 ↗
• InjuryMar 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AFTER AN OPEN ABDOMINAL HERNIA PROCEDURE, THE MESH GOT RIPPED AT THE MIDDLE AFTER THE PATIENT COUGHED AND HEARD A "POP". IT WAS NOTED THAT THE SIZE OF THE DEFECT WAS LESS THAN 13.8CM X 17.8CM. THE WOUND WAS CLOSED WITH A SUTURE AS A FIXATION SYSTEM AROUND THE MESH. THE PATIENT WAS TAKEN INTO SURGERY AGAIN TO REMOVE THE DAMAGED MESH. THE SECOND SURGERY WAS PERFORMED A DAY AFTER THE ORIGINAL PROCEDURE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE PATIENT WAS TO BE DISCHARGED BUT DUE TO THE INCIDENT AND SECOND SURGERY, THE PATIENT IS STILL ADMITTED TO THE HOSPITAL RESULTING TO A LONGER HOSPITAL STAY.

  Patient problems: No Code Available

  MAUDE report 8437735 ↗
• InjuryAug 9, 2018Migration 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 A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED ADHESIONS, MESH MIGRATION, RECURRENT HERNIA, SURGERY TO REMOVE MESH.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Injury; No Code Available; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 7768442 ↗
• InjuryApr 21, 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 A HERNIA REPAIR WITH MESH. THE ORIGINAL SURGERY WAS 2 YEARS AND 4 MONTHS AGO. THE PATIENT EXPERIENCED SURGICAL REVISION, PAIN, AND RECURRENCE.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 7449479 ↗
• InjuryApr 20, 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. PREOPERATIVE DIAGNOSIS AND POSTOPERATIVE DIAGNOSIS WAS VENTRAL INCISIONAL HERNIA. THE PROCEDURE PERFORMED WAS REPAIR OF VENTRAL INCISIONAL HERNIA WITH MESH. THE PATIENT EXPERIENCED SURGICAL REVISION, EVACUATION OF HEMATOMA, ABDOMINAL WASHOUT, VAC PLACED, PAIN, BLEEDING, BOWEL OBSTRUCTION, INFECTIONS.

  Patient problems: Blood Loss; Hematoma; Impaired Healing; Injury; No Code Available; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 7447898 ↗
• MalfunctionSep 15, 2017Adverse 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 IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Injury

  MAUDE report 6868400 ↗