Surgipro SPMM-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521101432), received between Sep 15, 2017 and Jan 30, 2023 — classified as 23 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2023Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, PAIN, SEXUAL DYSFUNCTION, ADHESIONS, INFLAMMATION, DISCOMFORT, MENTAL PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Inflammation; Nerve Damage; Pain; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 16269424 ↗
• InjuryJan 30, 2023Migration or Expulsion of Device; Material Integrity Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, PAIN, SEXUAL DYSFUNCTION, ADHESIONS, INFLAMMATION, DISCOMFORT, MENTAL PAIN, EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED PARTIAL REMOVAL OF MESH.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Emotional Changes; Inflammation; Nerve Damage; Pain; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 16269423 ↗
• InjuryAug 16, 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 THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH TORN AWAY ON RIGHT SIDE, ADHESIONS, RECURRENCE, AND MESH EROSION INTO VISCERA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIRED WITH MESH, EXPLANT OF MOST OF MESH, PARTIAL RESECTION OF OMENTUM, RIGHT/LEFT MYOFASCIAL ADVANCEMENT FLAPS, RESECTION OF SKIN/SUBCUTANEOUS TISSUE, AND SMALL BOWEL RESECTION.

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

  MAUDE report 12327846 ↗
• InjuryMay 20, 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 THERAPEUTIC TREATMENT OF A UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, INFLAMMATION, MESH MIGRATION, MENTAL PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, ADHESIONS, ABDOMINAL WALL MASS, MESH WADDED UP, FIBROTIC TISSUE, FLUID COLLECTION, SEROMA, HEMORRHAGE, THICK DENSE FIBROTIC WALL, NAUSEA, ABDOMINAL WALL PAIN, SCAR TISSUE, TENDERNESS, ABDOMINAL PAIN, RECURRENCE, DIARRHEA, SEROUS DISCHARGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, ABDOMINAL WALL MASS EXCISION, HERNIA REPAIR WITH MESH, REVISION SURGERY, CT SCAN, ABDOMINAL WALL EXPLORATION, USE OF ABDOMINAL BINDER, USE OF BLAKE DRAIN.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Diarrhea; Discomfort; Emotional Changes; Fibrosis; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Nausea; Nodule; Pain; Scar Tissue; Seroma; Unspecified Tissue Injury

  MAUDE report 11861117 ↗
• InjuryJan 25, 2021Material 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH CONTRACTION, PAIN, ABDOMINAL PAIN, EXPOSED MESH, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, ADMISSION TO HOSPITAL, LYSIS OF ADHESIONS, DIAGNOSTIC LAPAROSCOPY, SMALL BOWEL REPAIR, AND MESH/TACKS REMOVAL.

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

  MAUDE report 11222635 ↗
• 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11116334 ↗
• InjuryDec 5, 2020Material 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 RECURRENCE, BOWEL OBSTRUCTION, ADHESIONS, MRSA, DILATED BOWEL, SCARRING, EDEMATOUS/INFLAMMATORY TISSUE, TENDER, SEROMA, WINKLED MESH, ISCHEMIA, FISTULA, EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ADMISSION TO HOSPITAL, HERNIA REPAIR WITH NEW MESH, LYSIS OF ADHESIONS, REMOVAL OF MESH, VACUUM CLOSURE OF ABDOMEN, ENTEROTOMY REPAIR, REMOVAL OF WOUND VAC, DEBRIDEMENT OF SKIN/SUBCUTANEOUS TISSUE, SECONDARY CLOSURE OF WOUND, RIM OF SKIN INCISED, BOWEL RESECTION, CT SCAN.

  Patient problems: Adhesion(s); Bacterial Infection; Discomfort; Distress; Fistula; Hernia; Inflammation; Ischemia; Obstruction/Occlusion; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 10951049 ↗
• InjuryNov 26, 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 ABSCESS, ADHESIONS, FISTULA, INFECTION, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND BOWEL RESECTION.

  Patient problems: Abscess; Adhesion(s); Fistula; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10907369 ↗
• 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 A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 10897642 ↗
• InjuryMay 15, 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 THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cellulitis; Chills; Emotional Changes; Erythema; Fever; Fibrosis; Hernia; Hypersensitivity/Allergic reaction; Inflammation; Injury; Pain; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10063013 ↗
• InjuryApr 17, 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 RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Injury

  MAUDE report 9974309 ↗
• InjuryNov 15, 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 CHRONIC PAIN AND NERVE DAMAGE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Injury; Nerve Damage; Pain

  MAUDE report 9327833 ↗
• InjuryNov 14, 2019Migration 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 IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, SHOOTING NERVE PAIN, NERVE DAMAGE, SEXUAL DYSFUNCTION, SEVERE SCARRING, MESH "KNOTTING ," RESTRICTED MOVEMENT, DIFFICULTY PERFORMING DAILY ACTIVITIES, RELIANCE ON PAIN MEDICATIONS, DEPRESSION AND ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPEATED INJECTIONS AS WELL AS REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Distress; Emotional Changes; Hernia; Inflammation; Injury; Nerve Damage; No Code Available; Numbness; Pain; Scar Tissue; Scarring; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 9321244 ↗
• InjuryNov 14, 2019Migration 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 IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, SHOOTING NERVE PAIN, NERVE DAMAGE, SEXUAL DYSFUNCTION, SEVERE SCARRING, MESH "KNOTTING ," RESTRICTED MOVEMENT, DIFFICULTY PERFORMING DAILY ACTIVITIES, RELIANCE ON PAIN MEDICATIONS, DEPRESSION AND ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPEATED INJECTIONS AS WELL AS REMOVAL.

  Patient problems: Abdominal Distention; Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Distress; Emotional Changes; Hernia; Inflammation; Injury; Nerve Damage; No Code Available; Numbness; Pain; Scar Tissue; Scarring; Sexual Dysfunction; Unspecified Tissue Injury

  MAUDE report 9321232 ↗
• 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 RECURRENT HERNIA DUE TO FAILURE OF THE MESH AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 9251136 ↗
• 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 SURGICAL SITE INFECTION DUE TO FAILURE OF THE MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Failure of Implant; Injury; Unspecified Infection

  MAUDE report 9250967 ↗
• InjuryOct 1, 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, A THICK SCAR CAPSULE, EPIGASTRIC PERIUMBILICAL PAIN WITH NAUSEA AND CONSTIPATION. POST-OPERATIVE TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Constipation; Injury; Nausea; Pain; Scar Tissue

  MAUDE report 9141640 ↗
• InjuryMay 2, 2019Mechanics 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MACERATION, INFECTION, SWELLING AND OPEN DRAINING WOUND. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Discomfort; Emotional Changes; Fluid Discharge; Hematoma; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Inflammation; Injury; Muscle Weakness/Atrophy; No Code Available; Pain; Peritonitis; Swelling; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 8574915 ↗
• InjuryApr 18, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, WOUND OPENED SECONDARY TO LARGE HEMATOMA, INFECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, DRAINAGE OF RIGHT INGUINAL HEMATOMA, REMOVAL OF MESH, HERNIA REPAIRED WITH MESH.

  Patient problems: Hematoma; Hernia; Impaired Healing; Injury; Unspecified Infection

  MAUDE report 8528286 ↗
• InjuryMar 26, 2019Migration 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF PALPABLE DIRECT BILATERAL INGUINAL HERNIAS. THE PATIENT UNDERWENT BILATERAL LAPAROSCOPIC INGUINAL HERNIA REPAIR WITH A 10 X 15 CM PROGRIP MESH ON THE LEFT SIDE AND A 4 X 6 SURGIPRO ON THE RIGHT SIDE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION, NERVE DAMAGE, PAIN, RECURRING AND ONGOING DISCOMFORT, PERSISTENT CATCH IN LEFT GROIN, SCARRING, AND MESH FOLDED IN SEVERAL LOCATIONS ACCORDION STYLE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS AND NEURECTOMY.

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

  MAUDE report 8451929 ↗
• InjuryJan 18, 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 AN OPEN INCISIONAL HERNIORRHAPHY WITH MESH DUE TO A SUPRAUMBILICAL INCISIONAL HERNIA. THE PATIENT HAD REVISION SURGERY 3 YEARS AND 5 MONTHS POST-SURGERY. AT THAT TIME THE PATIENT UNDERWENT A LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH DUE TO RECURRENT INCISIONAL HERNIA, PERIUMBILICAL REGION. THE PATIENT EXPERIENCED REVISION, CHRONIC PAIN, AND ADHESIONS.

  Patient problems: Abdominal Distention; Adhesion(s); Cramp(s) /Muscle Spasm(s); Discomfort; Emotional Changes; Hernia; Inadequate Pain Relief; Injury; Muscle Spasm(s); No Code Available; Pain; Unspecified Tissue Injury

  MAUDE report 7203287 ↗
• InjuryDec 13, 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 A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED A RECURRENT VENTRAL HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED REPAIR OF RECURRENT VENTRAL HERNIA WITH MESH AND PREVIOUS MESH EXCISED. ON (B)(6) 2016 - RECURRENT VENTRAL HERNIA TREATED WITH BARD FLAT 3X6 30. ON (B)(6) 2019 - RECURRENT VENTRAL HERNIA TREATED WITH BARD 15X15.

  Patient problems: Hernia; Injury

  MAUDE report 7111790 ↗
• InjurySep 15, 2017Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PRE- AND POST-OP DIAGNOSIS: UNAVAILABLE- NO OP-REPORT. NAME OF PROCEDURE: UNAVAILABLE- NO OP-REPORT. OTHER RELEVANT HISTORY: CLAIMANT HAS HAD A SURGICAL REVISION; INFECTION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Erythema; Fluid Discharge; Granuloma; Hernia; Impaired Healing; Inflammation; Injury; Numbness; Pain; Ulcer; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 6869865 ↗