Symbotex SYM15Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 10884521190368), received between Jun 8, 2017 and Jun 1, 2026 — classified as 3 deaths, 191 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (99 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 196 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, NERVE DAMAGE, PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION, HERNIA REPAIR WITH NEW MESH, HOSPITALIZATION.

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

  MAUDE report 25349889 ↗
• InjuryMay 5, 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 A VENTRAL AND INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Distress; Unspecified Tissue Injury

  MAUDE report 25084077 ↗
• InjuryApr 2, 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LAPAROSCOPIC ROBOTIC SLEEVE GASTRECTOMY, HIATAL HERNIA REPAIR, BOWEL REMOVAL, LYSIS OF ADHESIONS AND MESH REVISION.

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

  MAUDE report 24766890 ↗
• InjuryNov 24, 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 AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, SEROMA, EMOTIONAL INJURIES, HERNIA INCARCERATION, HARD LUMP ON SURGICAL SITE, DISRUPTION IN SLEEP. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hernia; Nodule; Obstruction/Occlusion; Pain; Seroma; Sleep Dysfunction; Unspecified Tissue Injury

  MAUDE report 23639001 ↗
• InjuryOct 23, 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 A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, OPEN WOUND, DISCHARGE WITH ODOR, SINUS TRACT, FISTULA, INFECTION, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, REVISION SURGERY, ABDOMINAL WALL REPAIR, WOUND VAC, CLOSURE OF OPEN WOUND, MESH DEBRIDEMENT AND ELECTROCAUTERY, WOUND IRRIGATION.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Fistula; Fluid Discharge; Hernia; Impaired Healing; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23368442 ↗
• InjuryJul 18, 2025Material 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 PAIN, RECURRENCE, HEMATOMA, INFLAMMATION, ADHESIONS, OBSTRUCTION AND MESH EVENTRATION INTO HERNIA SAC. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

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

  MAUDE report 22545904 ↗
• InjuryMay 21, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22066480 ↗
• InjuryMay 14, 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 PAIN, RECURRENCE, INFLAMMATION, NAUSEA, VOMITING, CONSTIPATION, DIGESTION ISSUES, ACID REFLUX. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND GALLBLADDER RESECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Hernia; Inflammation; Nausea; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury; Vomiting

  MAUDE report 22019779 ↗
• InjuryApr 8, 2025Migration or Expulsion of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 BLOODY STOOL, TESTICULAR TORSION, MESH WRINKLED, MESH BALLED, ADHESIONS, RECURRENCE, MESH SHRINKAGE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ORCHIECTOMY AND MESH REVISION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 21798751 ↗
• InjuryFeb 10, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, RECURRENCE, INFLAMMATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

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

  MAUDE report 21351415 ↗
• InjuryJan 22, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, DIFFICULTY HAVING BOWEL MOVEMENT, OBSTRUCTION, & SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL, HERNIA REPAIR WITH NEW MESH, & HERNIA REPAIR.

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

  MAUDE report 21208994 ↗
• InjuryJan 17, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, RECURRENCE, PAIN, SUFFERING, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED TAKEDOWN OF OMENTUM, REVISION SURGERY, RESECTION OF MESH, HERNIA REPAIR AND PARTIAL OMENTECTOMY.

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

  MAUDE report 21185548 ↗
• InjuryDec 10, 2024Migration or Expulsion of Device; Material Deformation; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; 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 AN UMBILICAL VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, MESH CONTRACTION, MESH BALLED, MESH EVENTRATION, DISCOMFORT, INFLAMMATION, RECURRENCE, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION.

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

  MAUDE report 20894456 ↗
• InjuryNov 18, 2024Adverse 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, PERFORATION, EROSION, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, EXPLORATORY LAPAROTOMY, REMOVAL OF INFECTED MESH, REPAIR OF SMALL BOWEL PERFORATION, SMALL BOWEL RESECTION AND SMALL BOWEL REPAIR.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Cramp(s) /Muscle Spasm(s); Discomfort; Erosion; Granuloma; Hernia; Inflammation; Pain; Perforation; Pneumoperitoneum; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20712477 ↗
• InjuryAug 29, 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, INFLAMMATION, PAIN, BLOATING, EXCESS GAS, BLOOD LOSS, AND HERNIA RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abdominal Distention; Abdominal Pain; Flatus; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 20103753 ↗
• InjuryAug 5, 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; 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 IMPLANT, THE PATIENT EXPERIENCED INFECTION, PERFORATION, PERITONITIS, DEFECTIVE MESH, ABDOMINAL PAIN, BOWEL OBSTRUCTION, ISCHEMIA, ADHESIONS, ENTEROTOMY, PURULENT DISCHARGE, HYPOVOLEMIC SHOCK, INFLAMMATION, DISCOMFORT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, INTENSIVE CARE (ICU), CT SCAN, COLECTOMY, LYSIS OF ADHESIONS, VASOPRESSORS, WOUND VAC, MESH REMOVAL, JP DRAIN PLACEMENT, MEDICATION, PUT ON VENTILATOR, SMALL BOWEL RESECTION.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Discomfort; Emotional Changes; Hypovolemic Shock; Inflammation; Ischemia; Nausea; Obstruction/Occlusion; Pain; Perforation; Peritonitis; Purulent Discharge; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 19913122 ↗
• InjuryJul 19, 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, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS.

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

  MAUDE report 19782014 ↗
• 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, ADHESIONS, 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.

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

  MAUDE report 19461780 ↗
• InjuryMay 14, 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, RECURRENCE, ADHESIONS, ABDOMINAL WALL DIASTASIS, MUSCLE LOCK UP IN STOMACH UNDER RIBS, AND NEEDLE FEELING UNDER SKIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Discomfort; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 19312536 ↗
• InjuryMay 1, 2024Migration 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 MESH MIGRATION, PAIN, RECURRENCE, ADHESIONS, OBSTRUCTION, SMALL BOWEL ENTRAPMENT, AND ON DISABILITY NOW DUE TO SEVERE BOWEL PROBLEMS STEMMING FROM LAST HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, SMALL BOWEL RESECTION, APPENDECTOMY, ROBOTIC LAPAROSCOPY, HERNIA REPAIR, RELEASE OF SMALL BOWEL OBSTRUCTION, LAPAROSCOPY CONVERTED TO EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, EXCISION OF POSTERIOR RECTUS SHEATH, AND SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Constipation; Electrolyte Imbalance; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Ischemia; Nausea; Necrosis; Obstruction/Occlusion; Pain; Seroma; Unspecified Tissue Injury; Vomiting; Wound Dehiscence

  MAUDE report 19222595 ↗
• InjuryMar 20, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, ADHESIONS, BULGING, ABDOMINAL WALL FLUID COLLECTION, INFLAMMATION, INFECTION, SCARRING, NERVE DAMAGE, MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, SEROSANGUINOUS FLUID, ABDOMINAL PAIN, & OOZING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH MESH, INCISIONAL HERNIA REPAIR, CT SCAN, CT GUIDED ASPIRATION OF FLUID COLLECTION, PAIN MEDICATION, COMPONENT SEPARATION, DIAGNOSTIC LAP, & LYSIS OF ADHESIONS.

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

  MAUDE report 18941314 ↗
• InjuryMar 20, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL WALL FLUID COLLECTION, SEROSANGUINOUS FLUID, ABDOMINAL PAIN, ADHESIONS, OOZING. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, CT GUIDED FLUID COLLECTION ASPIRATION, COMPONENT SEPARATION, PAIN MEDICATION, DIAGNOSTIC LAP, LYSIS OF ADHESIONS.

  Patient problems: Abdominal Pain; Adhesion(s); Ascites; Fluid Discharge; Unspecified Tissue Injury

  MAUDE report 18941306 ↗
• InjuryMar 12, 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 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 PARTIAL REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, TAKEDOWN OF ADHESIONS.

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

  MAUDE report 18887912 ↗
• InjuryMar 5, 2024Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Deformation; 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, MESH EVENTRATION, ABDOMINAL PAIN, RECURRENCE, DIASTASES, INFLAMMATION, ADHESIONS, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, REPAIR OF DIASTASES.

  Patient problems: Abdominal Pain; Adhesion(s); Cramp(s) /Muscle Spasm(s); Emotional Changes; Hernia; Inflammation; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18839548 ↗
• InjuryFeb 5, 2024Migration 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 THERAPEUTIC TREATMENT OF A VENTRAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, DEFECTIVE MESH, FAILURE OF MESH, RECURRENCE, ADHESIONS, DISFIGUREMENT, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DISABILITY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Emotional Changes; Hernia; Hypersensitivity/Allergic reaction; Muscle Weakness/Atrophy; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18647237 ↗