Symbotex SYM1710ERecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521190412), received between Oct 17, 2017 and Jun 11, 2026 — classified as 1 death, 45 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (17 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Migration 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT, BLOATING, ADHESIONS, MESH ENCAPSULATION, RECURRENCE, PAIN, SUFFERING, MESH MIGRATION AND BULGE IN ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH.

  Patient problems: Abdominal Distention; Adhesion(s); Discomfort; Foreign Body Reaction; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25473557 ↗
• InjuryApr 20, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIC ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24926258 ↗
• InjuryNov 20, 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 IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, HEARTBURN.

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

  MAUDE report 23606792 ↗
• InjurySep 15, 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, ADHESIONS, SWELLING/ EDEMA, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 23059844 ↗
• InjuryJul 22, 2025Mechanics 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 PAIN, RECURRENCE, ADHESIONS, MESH FAILURE, AND BOWEL BLOCKAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, ADHESIOLYSIS, HERNIA REPAIR WITH NEW MESH AND HOSPITALIZATION.

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

  MAUDE report 22567869 ↗
• InjuryApr 23, 2025Mechanics 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, RECURRENCE, ADHESIONS, EMOTIONAL HARM, MESH FAILURE, NUMBNESS, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION AND ADHESIOLYSIS.

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

  MAUDE report 21896569 ↗
• InjuryMar 26, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, PAIN, INFECTION, RECURRENCE, INFLAMMATION, ADHESIONS, SEROMA, FIBROSIS, NECROSIS, FOREIGN BODY REACTION, GRANULOMA, ABSCESS, ALLERGIC REACTION, BLEEDING, ANXIETY, DEPRESSION, PTSD, INABILITY TO PERFORM DAILY ACTIVITIES, POORLY HEALING WOUND, BURIED PENIS SECONDARY TO EDEMA, SIGNIFICANT PURULENCE, GROSSLY ABNORMAL HYDROCELE, FIBROUS PSEUDOTUMOR, SEMINIFEROUS TUBULES WITH ATROPHIC CHANGES, WEAK SKIN TISSUE, SKIN EASILY TORE WITH LIGHT MANUAL TENSION, VASCULAR CONGESTION, AND NONVIABLE TISSUE AT BASE OR SCROTUM. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, DIAGNOSTIC LAPAROSCOPY, PARTIAL OMENTECTOMY, INCISION DRAINAGE, EXTENSIVE DEBRIDEMENT, AND MEDICATION.

  Patient problems: Abscess; Adhesion(s); Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiovascular Dysfunction/Insufficiency; Depression; Distress; Fibrosis; Foreign Body Reaction; Granuloma; Hemorrhage/Blood Loss/Bleeding; Hernia; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Necrosis; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Unspecified Vascular Problem

  MAUDE report 21702310 ↗
• InjurySep 5, 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, HEMATOMA, ALLERGIC REACTION, OBSTRUCTION, FISTULA, SEROMA, ARTHRITIS, PAIN, INFLAMMATION, HERNIA, ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, HERNIA REPAIR WITH NEW MESH, MEDICATION.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Ascites; Bacterial Infection; Blister; Cellulitis; Fistula; Fluid Discharge; Hematoma; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20152102 ↗
• InjuryJul 30, 2024Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, INFLAMMATION, ADHESIONS, OBSTRUCTION, FISTULA, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MULTIPLE SURGERIES, MEDICATION, OSTOMY BAG USE, PARTIAL EXCISION OF MESH, CYSTOSCOPY, BILATERAL URETERAL STENT PLACEMENTS, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, LOW ANTERIOR RESECTION, RESECTION OF TERMINAL ILEUM WITH THE RECTUM, PERITONEAL LAVAGE, ABTHERA PLACEMENT, MESH EXPLANT, RE-EXPLORATORY LAPAROTOMY, COLECTOMY, RIGHT HEMICOLECTOMY, OMENTECTOMY, THERAPEUTIC PERITONEAL LAVAGE, MOBILIZATION OF SPLENIC FLEXURE OF COLON, PRIMARY ILEOCOLONIC ANASTOMOSIS, CREATION OF END DESCENDING COLONIC COLOSTOMY, DELAYED ABDOMINAL WALL CLOSURE AND WOUND VAC OVER INCISION.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Emotional Changes; Fistula; Inflammation; Obstruction/Occlusion; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19863606 ↗
• InjuryFeb 5, 2024Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; 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 A PARACOLOSTOMY 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, BILATERAL RECTUS ABDOMINIS COMPONENT SEPARATION, COLOSTOMY TAKEDOWN, SEGMENTAL COLON RESECTION.

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

  MAUDE report 18646673 ↗
• InjuryJan 23, 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 MESH MIGRATION, MESH EXPULSION, DEFECTIVE MESH, ABDOMINAL PAIN, RECURRENCE, SCARRING, PAIN, MENTAL PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH, ABDOMINAL WALL RECONSTRUCTION.

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

  MAUDE report 18565165 ↗
• InjuryDec 13, 2023Mechanics 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 SUPRAUMBILICAL 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, SMALL BOWEL RESECTION.

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

  MAUDE report 18322964 ↗
• InjuryDec 7, 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, 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Numbness; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 18287401 ↗
• InjuryMar 31, 2023Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE AND ACUTE CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 16656891 ↗
• InjuryFeb 7, 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 SUFFERING, DEFECTIVE DEVICE, LOSS OF ENJOYMENT OF LIFE, PAIN, MENTAL PAIN, ABDOMINAL PAIN, RECURRENCE, ADHESIONS, INFLAMMATION, SCARRING, AND IMPAIRMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, RECURRENT HERNIA REPAIR, AND LYSIS OF ADHESIONS.

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

  MAUDE report 16315235 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, ABDOMINAL PAIN, NAUSEA, VOMITING, AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADHESIOLYSIS, HERNIA REPAIR WITH NEW MESH, AND REMOVAL OF MESH.

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

  MAUDE report 11118711 ↗
• 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, ABDOMINAL PAIN, NAUSEA, VOMITING, AND SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADHESIOLYSIS, HERNIA REPAIR WITH NEW MESH, AND REMOVAL OF MESH.

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

  MAUDE report 11116407 ↗
• InjuryNov 16, 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, SMALL BOWEL OBSTRUCTION, INCARCERATION, RECURRENCE, PAIN, SCARRING, INFLAMMATION, AND DISFIGUREMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL ENTEROTOMY, DESEASONALIZATION, AND MESH REMOVAL SURGERIES.

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

  MAUDE report 10848435 ↗
• InjuryNov 16, 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 HERNIA RECURRENCE, INCARCERATED SMALL BOWEL, ADHESIONS, INFECTION, CHRONIC PAIN, MENTAL PAIN, SCARRING, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, AND SWELLING ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION, TAKEDOWN OF ADHESIONS, REVISION SURGERY, MESH REMOVAL AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Adhesion(s); Emotional Changes; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 10847717 ↗
• InjuryOct 6, 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 AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, MENTAL PAIN, PAIN, SUFFERING, DEVICE DEFECTIVE, MESH FAILURE, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE/COMFORT/CONSORTIUM, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL OF MESH AND REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Failure of Implant; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10639668 ↗
• InjurySep 18, 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 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, SEROMA, SINUS TRACT, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Foreign Body Reaction; Hernia; Inflammation; Injury; No Code Available; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 10555721 ↗
• InjuryJul 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, RECURRENT ABDOMINAL BULGE, AND RECTUS DIASTASIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abdominal Distention; Adhesion(s); Injury; No Code Available; Pain

  MAUDE report 10319735 ↗
• InjuryJul 9, 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE OF HERNIA, HEMATOMA, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DEBRIDEMENT, REMOVAL OF OLD MESH, SMALL BOWEL RESECTION, HERNIA REPAIR WITH NEW MESH, COMPONENT OF SEPARATION, LYSIS OF ADHESIONS, AND TISSUE TRANSFER TO THE RIGHT AND LEFT AS WELL AS PLACEMENT OF BIOLOGICAL MESH.

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

  MAUDE report 10252153 ↗
• 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, PAIN, PULMONARY ATELECTASIS, AND DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Hernia; Inflammation; Injury; No Code Available; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 10248238 ↗
• InjuryJun 5, 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 A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFECTION, PAIN, RECURRENCE, AND SWELLING. 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; Constipation; Emotional Changes; Hernia; Injury; Pain; Scar Tissue; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10124623 ↗