Symbotex SYM3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521190511), received between Oct 11, 2017 and May 29, 2026 — classified as 1 death, 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (24 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25333546 ↗
• DeathJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN VENTRAL HERNIA PROCEDURE ON A PATIENT DUE TO HERNIA INCARCERATION, MECHANICAL ILEUS, AND VISCERAL ATTACHMENTS AS RESULT OF PREVIOUS MEDICAL CONDITION, A MESH WAS USED IN IDEAL CONDITION USING THE INLAY TECHNIQUE AND WAS FIXATED BY SUTURES. HOWEVER, THREE MONTHS LATER, THE PATIENT CAME TO THE HOSPITAL WITH HYPERTENSION, HEART FIBRILLATION, AND WITH CLINICAL PICTURE OF ACUTE ABDOMEN. THE PATIENT HAD TISSUE DAMAGE DUE TO INTESTINAL PERFORATION. THE SURGEON PERFORMED EXTIRPATION OF PARTS OF THE MESH, RESECTION OF SMALL INTESTINES, ILEOSTOMY WITH TERMINAL ILEOFISTULA, AND DRAINAGE. THE PATIENT DIED A DAY AFTER THE PROCEDURE.

  Patient problems: Atrial Fibrillation; Bowel Perforation; High Blood Pressure/ Hypertension; Necrosis; Tissue Breakdown

  MAUDE report 19490305 ↗
• InjuryFeb 27, 2024Degraded; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Degraded; 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH CALCIFICATION, MESH SHRINKAGE/CONTRACTURE, MESH WRINKLED UP IN APPEARANCE, PAIN, RECURRENCE, ADHESIONS, ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED PCA PUMP, PAIN MEDICATION.

  Patient problems: Abdominal Pain; Adhesion(s); Calcium Deposits/Calcification; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 18791189 ↗
• 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, SMALL BOWEL OBSTRUCTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, EXPLORATORY LAPAROTOMY, SMALL BOWEL ANASTOMOSIS, APPENDECTOMY, HERNIA SAC EXCISION, PRIMARY FASCIAL CLOSURE, WOUND VAC PLACEMENT.

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

  MAUDE report 18124144 ↗
• InjuryJun 14, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; 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 AN INCISIONAL HERNIA. IT WAS REPORTED, THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABSCESS, INFECTION, RECURRENCE, SEROMA, ADHESIONS, FISTULA, INFLAMMATION, SCARRING, MESH EXPOSURE AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC..

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

  MAUDE report 17128104 ↗
• 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FAILURE OF MESH, DEFECTIVE MESH, PAIN, ADHESIONS, RECURRENCE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

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

  MAUDE report 16512813 ↗
• InjuryJan 27, 2023Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Deformation; 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 CHRONIC ABDOMINAL WOUND, MESH FAILURE, MESH UNINCORPORATION, MESH INVAGINATION, INCARCERATION OF HERNIA, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, FISTULA, ABSCESS, AND CELLULITIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, INCISION AND DRAINAGE OF ABSCESS, DEBRIDEMENT, WOUND VAC, USE OF JP DRAIN AND BLAKE DRAIN.

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

  MAUDE report 16256701 ↗
• InjuryDec 29, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, OBSTRUCTION, AND FOLDING MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, AND MEDICATION.

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

  MAUDE report 16068887 ↗
• InjuryOct 5, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, PERFORATION, SMALL BOWEL SEROSAL INJURY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, BOWEL RESECTION, WOUND VAC, AND JP DRAIN.

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

  MAUDE report 15544182 ↗
• InjurySep 24, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND JP DRAIN PLACEMENT.

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

  MAUDE report 15477548 ↗
• InjurySep 16, 2022Material 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, INFLAMMATION, ADHESIONS, SHRUNKEN MESH.

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

  MAUDE report 15438970 ↗
• InjuryAug 29, 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, INFLAMMATION, ADHESIONS, AND OBSTRUCTION. POST OPERATIVE TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 15311797 ↗
• InjuryJul 21, 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 ONLAY IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Emotional Changes; Impaired Healing; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15076765 ↗
• InjuryJul 21, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, ADHESIONS, RECURRENCE, MESH FAILURE, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND DEFECTIVE DEVICE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, AND REMOVAL OF MESH.

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

  MAUDE report 15075757 ↗
• InjuryJun 23, 2022Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Deformation; 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 INCISIONAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, MENTAL PAIN, SUFFERING, RECURRENCE, CURLING AND OUTPOUCHING OF THE MESH, HERNIATION OF ADHESIVE SMALL BOWEL LOOPS, ADHESIONS, FRACTURED MESH, DEFECTIVE DEVICE, INFLAMMATION, DISFIGURATION, DISCOMFORT, MENTAL ANGUISH, SCARRING, IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, IMAGING REQUIRED, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, BILATERAL MYOFASCIAL RELEASE AND POSTERIOR COMPONENT SEPARATION.

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

  MAUDE report 14790673 ↗
• InjuryJun 2, 2022Mechanics 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 RECURRENCE, SMALL BOWEL OBSTRUCTION, ADHESIONS, PAIN, INFLAMMATION, DEFECTIVE DEVICE, MENTAL PAIN, SUFFERING, SCARRING, PERMANENT IMPAIRMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED BOWEL RESECTION, REVISION SURGERY, MESH REMOVAL, AND PARTIAL MESH REMOVAL, LYSIS OF ADHESIONS, HOSPITALIZATION, REPAIR OF THE UTERINE WALL.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Emotional Changes; Granuloma; Hematoma; Hernia; Inflammation; Low Blood Pressure/ Hypotension; Nodule; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Unspecified Vascular Problem

  MAUDE report 14575941 ↗
• InjuryAug 19, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED UNATTACHED PORTION OF MESH, ADHESIONS, SCARRING, BOWEL OBSTRUCTION, DENUDED ABDOMINAL WALL, PURULENT DRAINAGE, ABDOMINAL PAIN, HERNIA RECURRENCE, LIPOMA, NAUSEA, INFLAMMATION, LOSS OF APPETITE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Discomfort; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Nausea; Nodule; Obstruction/Occlusion; Pain; Perforation; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 12344938 ↗
• InjuryJun 18, 2021Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 LAPAROSCOPIC INCISIONAL HERNIA AND AN OPEN EPIGASTRIC INCISIONAL HERNIA. THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH PULLED AWAY, OMENTUM AND BOWEL WERE PROTRUDING THROUGH PRIOR MESH, DRAINAGE OF SEROMA THROUGH ABDOMINAL WALL, PRIOR MESH APPEARED TO BE DISTORTED/PALPATED, ABSCESS, MESH EROSION, FLUID FILLED ABDOMINAL WALL, PERITONEAL FLUID, DEFECTIVE MESH, INFLAMMATION, SCARRING, MENTAL PAIN, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, REMOVAL OF MESH, HERNIA REPAIR SURGERY WITH MESH, CATHETER PLACEMENT, DRAINAGE SURGERY, BILATERAL TRANSVERSUS ABDOMINIS RELEASE, SEROMA DRAINED, SEROMA FLUID ASPIRATED, AND MYOFASCIAL COMPONENT SEPARATION.

  Patient problems: Abscess; Adhesion(s); Ascites; Discomfort; Emotional Changes; Erosion; Fluid Discharge; Hernia; Inflammation; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 12029163 ↗
• InjuryMay 18, 2021Migration 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 ADHESIONS, MESH DETACHMENT, OPEN DRAINING WOUND, SEROMA, INFECTION, EXPOSED MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Fluid Discharge; Hernia; Impaired Healing; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11846158 ↗
• InjuryMay 14, 2021Migration 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS, PAIN, ABDOMINAL PAIN, MESH SLIPPED/CURLED, MESH FAILURE, BLEEDING, INFLAMMATION, ENTEROCOLITIS, FLUID COLLECTION, NAUSEA, ABDOMINAL BULGE, HYPOTENSION, VOMITING, DIARRHEA, ABDOMINAL PAIN, RASH, SWELLING, PULLING SENSATION, AND SEROMA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR USING SUTURES, HERNIA REPAIR WITH MESH, REMOVAL OF MESH, TRANSVERSUS ABDOMINIS RELEASE, PANNICULECTOMY, REMOVAL OF TACKS, EXCESS SKIN/HERNIA SAC REMOVED, SMALL BOWEL RESECTION, CT SCAN, PCA PUMP, FLUID BOLUS, ADMISSION TO HOSPITAL, AND MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Ascites; Diarrhea; Discomfort; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Low Blood Pressure/ Hypotension; Nausea; Obstruction/Occlusion; Pain; Rash; Seroma; Swelling/ Edema; Unspecified Tissue Injury; Vomiting

  MAUDE report 11828649 ↗
• 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 ADHESIONS OF THE DISTAL ILEUM TO MESH, INFECTION, FISTULA, ABSCESS, DRAINAGE, PARTIAL BOWEL OBSTRUCTION, FOLDED MESH, DRAINING SINUS TRACT, RECURRENCE, FLUID COLLECTION, FOREIGN BODY GIANT CELL REACTION, ABDOMINAL PAIN, SEROMA, FEVER, INFLAMMATION, BLOATING, CRAMPING, NAUSEA, DRY HEAVES, CHILLS, DIARRHEA, LOSS OF APPETITE, RASH, PAIN, STRETCHED MESH, SEROSAL TEAR, AND PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, MESH EXPLANT, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, EXCISION OF DRAINING SINUS TRACT, TPN, EVACUATION OF PURULENT FLUID COLLECTION, CT SCAN, WOUND VAC, POCKET OF INFLAMMATORY CHANGE OPENED UP AND LAVAGED, MEDICATION, ADMISSION TO HOSPITAL, PICC LINE, PCA PUMP, DRAIN PLACED, 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 11825196 ↗
• InjuryApr 18, 2021Degraded; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; Material Integrity 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 RIGHT FLANK HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, PAIN, MENTAL ANGUISH, SCARRING, DISFIGUREMENT, DEFORMITY, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, ABDOMINAL PAIN, HERNIA RECURRENCE, SEROMA, MESH FAILURE, CONTRACTED MESH, TISSUE SCARIFICATION, INFLAMMATION, ADHESIONS, FOREIGN BODY REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, MESH EXPLANTED, AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Failure of Implant; Foreign Body Reaction; Hematoma; Hernia; Inflammation; Muscle Weakness/Atrophy; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 11683628 ↗
• InjuryJan 25, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION, RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 11222899 ↗
• InjuryJan 22, 2021Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL LEFT FLANK HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MIGRATION, MESH DEHISCED, RECURRENCE, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 11214582 ↗
• InjuryJan 6, 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 AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11123232 ↗