BARD 0112670Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741016523), received between Mar 28, 2017 and Dec 5, 2025 — classified as 1 death, 50 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (42 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A SMALL DEFECT WAS IDENTIFIED IN MIDLINE ABOVE UMBILICUS. THEN, A BARD FLAT MESH (DEVICE 1) WAS LAID OVER THE TOP AND TACKED USING SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF KUGEL PATCH (DEVICE 2). PER OP NOTES, ¿THERE WERE NOTED TO BE TWO AREAS WHERE THE FASCIA HAD WEAKENED IN THE MIDLINE. THE SMALL OVAL KUGEL PATCH (DEVICE 2) WAS LAID OVERLYING THE FASCIA AND TACKED USING SUTURES CIRCUMFERENTIALLY.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC PAIN AND SWELLING FROM ABDOMINAL WALL MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2). PER OP NOTES, ¿THE MESH (DEVICE 1, 2) WAS COMPLETELY EXCISED. THERE WERE SEVERAL SMALL DEFECTS OF THE FASCIA AND ANTERIOR RECTUS SHEATH, WHICH WERE IDENTIFIED AND WERE CLOSED WITH SUTURES."

  Patient problems: Hematoma; Hernia; Swelling/ Edema

  MAUDE report 23727471 ↗
• InjuryOct 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS ALLEGED ON (B)(6) 2015, THE PATIENT UNDERWENT A TOT (TRANSOBTURATOR TAPE) PROCEDURE FOR TREATMENT OF URGE INCONTINENCE AND WAS IMPLANTED WITH MESH. AS REPORTED ON (B)(6) 2015, THE PATIENT EXPERIENCED UTI, URGE INCONTINENCE AND RETURNED TO HOSPITAL DURING WHICH THE PATIENT WAS PUT ON ANTIBIOTICS. IT WAS REPORTED THAT OVER THE NEXT FEW YEARS THE PATIENT HAD BACK PAIN, RECURRING UTI'S, PAIN ON THE RIGHT SIDE, PAINFUL SEX, AUTOIMMUNE ISSUES INCLUDING VITILIGO, LICHEN SCLEROSIS, DIVERTICULITIS AND URGE INCONTINENCE. REPORTEDLY THE PATIENT HAD PRE-OP ON (B)(6) 2024 AND HAS BEEN WAITING FOR A DATE FOR REMOVAL OF THE TOT MESH. NOTE: THE INFORMATION PROVIDED BY THE CONTACT LISTS LOT NUMBERS FOR TWO DEVICES AN ADJUSTABLE SINGLE-INCISION SLING USED TO TREAT STRESS URINARY INCONTINENCE AND A BARD FLAT MESH.

  Patient problems: Autoimmune Disorder; Incontinence; Pain; Urinary Tract Infection

  MAUDE report 20345197 ↗
• InjuryJul 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN BARD MESH (BARD FLAT MESH) (CAT #0112670 AND LOT #HUWL1294) ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 19759316 ↗
• InjuryMay 3, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MARLEX MESH (BARD FLAT MESH) ON (B)(6)2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST MARLEX MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 16858416 ↗
• InjuryDec 20, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 16012507 ↗
• InjuryAug 6, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MARLEX (BARD FLAT MESH). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALSO ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12286046 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER MEDICAL RECORDS AND PLAINTIFF PROFILE FORM: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH. PER OPERATIVE NOTES, ¿HERNIA SAC WAS REDUCED. THEN A BARD FLAT MESH WAS USED FOR REPAIR AND SECURED TO THE INGUINAL LIGAMENT USING SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, SCAR TISSUE AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF BARD FLAT MESH. PER OPERATIVE NOTES, ¿SWELLING ALONG WITH RECURRENT HERNIA WAS NOTED IN

  Patient problems: Hernia; Insufficient Information; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 12101450 ↗
• InjuryFeb 3, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2005 AND/OR (B)(6) 2011 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2010, (B)(6) 2011 AND/OR (B)(6) 2013. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain; Seroma

  MAUDE report 11271555 ↗
• InjuryDec 16, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY AND MEDICAL RECORDS: ON (B)(6) 2013 A (B)(6) YEAR OLD FEMALE PATIENT WITH A HISTORY OF TOTAL PROLAPSE, STRESS URINARY INCONTINENCE AND AN INDWELLING PESSARY WAS SCHEDULED FOR CYSTOCELE, RECTOCELE REPAIR, VAGINAL HYSTERECTOMY AND A SLING PROCEDURE. PER THE OPERATIVE REPORT DETAILS, FOLLOWING REMOVAL OF THE UTERUS, THE ANTERIOR VAGINAL WALL WAS OPENED TO ACCESS THE RETROPUBIC SPACE ¿USING A STRIP OF MARLEX MESH (BARD FLAT), APPROXIMATELY 1.5 CM WIDE AND 8 CM LONG, THE SLING WAS SOAKED IN GENTAMICIN IRRIGATION. AT EITHER END OF THE SLING, A #1 PROLENE SUTURE WAS PLACED. THE PROLENE SUTURE WAS GRASPED AND BROUGHT UP INTO THE SUPRAPUBIC AREA. THIS POSITIONED THE SLING IN THE PROPER LOCATION. ADEQUATE TENSION WAS CREATED ON THE SLING.¿ A SUPRAPUBIC TUBE WAS PLACED; CYSTOSCOPY CONFIRMED PATENCY OF THE BLADDER, THE PROCEDURE WAS COMPLETED, AND SKIN CLOSURE WAS ACHIEVED. ON (B)(6) 2015 THE PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND WAS SCHEDULED FOR EXPLORATORY LAPAROTOMY AND LYSIS OF ADHESIONS. PER THE OPERATIVE REPORT DETAILS, THE PERITONEAL CAVITY WAS ENTERED, AND THE SMALL BOWEL WAS RUN UNTIL THE AREA OF OBSTRUCTION WAS REAC

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 11022890 ↗
• MalfunctionDec 16, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, ON (B)(6) 2020 PRIOR TO AN OPEN PROCEDURE OUTSIDE THE OPERATING ROOM, THE BARD FLAT MESH PACKAGE WAS NOTED TO BE DAMAGED AND THERE WAS A CONCERN FOR STERILITY BREACH. THERE WAS NO PATIENT INVOLVEMENT. THE MESH WAS DISCARDED AND A NEW MESH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 11018375 ↗
• InjuryNov 19, 2020Defective Device; Defective Device

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY AND MEDICAL RECORDS: 31-OCT-2008 - A FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF VAGINAL VAULT PROLAPSE AND ENTEROCELE FORMATION WAS SCHEDULED FOR REPAIR, UNDERWENT BILATERAL SALPINGO-OOPHORECTOMY AND IMPLANT OF TRELEX GRAFT (BARD/DAVOL FLAT MESH). THIS WAS SECURED TO THE VAGINAL APEX BY CV-0 NON-BARD/DAVOL (GORE-TEX) SUTURES. HALBAN CULDOPEXY PROCEDURE WAS THEN PERFORMED. THE TRELEX GRAFT (BARD/DAVOL FLAT MESH) WAS SHORTENED AND SECURED INTO THE PERIOSTEUM WITH THE PREVIOUSLY PLACED SUTURE, IN-FOLDING THE ROUGH EDGES OF THE GRAFT DURING LIGATION; FASCIA AND SKIN CLOSURE WAS ACHIEVED.

  Patient problems: Injury

  MAUDE report 10867383 ↗
• InjurySep 30, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR ¿PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain; Post Operative Wound Infection; Seroma; Wound Dehiscence

  MAUDE report 10605780 ↗
• InjurySep 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5095893): "INGUINAL HERNIA/BULGE IN THE ABDOMINAL WALL/FIRST NOTICED AFTER DOING SIT-UPS ABOUT 4 MONTHS EARLIER HAD BARD SURGICAL REPAIR WITH MESH. STARTED HAVING PAIN AND ON (B)(6) 2020 DUE TO SHOOTING AND RADIATING PAIN IN ABDOMEN HE HAD IT REMOVED AT (B)(6) ONCE REMOVED DOING GREAT NO ISSUES." THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE CONTACT: (B)(6) 2015: THE PATIENT UNDERWENT AN OPEN UMBILICAL HERNIA REPAIR WITH IMPLANT OF A BARD/DAVOL 2X12" FLAT MESH. (B)(6) 2019: ABOUT 4 YEARS LATER, THE PATIENT HAD MULTIPLE COMPLAINTS OF SHARP ABD PAIN AND DISCOMFORT. (B)(6) 2019: THE PATIENT HAD A SURGEON CONSULTATION WHO EXAMINED THE PATIENT; AS REPORTED DURING THE EXAM THE PATIENT FELT "RIPPING AND TEARING," AND THE SURGEON STATED HE DID NOT FEEL A HERNIA. AS REPORTED THE PAIN WORSENED FOR THE PATIENT AFTER THE EXAM. (B)(6) 2019: AN ABDOMINAL CT INDICATED A NORMAL CT SCAN WITH NO EVIDENCE OF HERNIA RECURRENCE. (B)(6) 2020: THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE WITH EXPLANT OF THE BARD/DAVOL FLAT MESH. (B)(6) 2020: THE PATIENT HAD A FOLLOW UP PHONE CALL (TELEMEDICINE) DUE TO COVID-19 WITH SURGEON AND REP

  Patient problems: Abdominal Pain; Pain

  MAUDE report 10540681 ↗
• InjuryMar 4, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BARD MESH (BARD FLAT MESH). IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SMALL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH. PER OPERATIVE NOTES, ¿A BARD FLAT MESH WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH EXPOSED PORTION OF OLD MESH AT PREVIOUS HERNIA SITE, PAIN THEREBY UNDERWENT AN OPEN REPAIR WITH EXPLANT OF BARD FLAT MESH. PER OPERATIVE NOTES, ¿PREVIOUS MESH WAS EXPOSED. OLD BARD FLAT MESH WAS REMOVED.¿.¿

  Patient problems: Disability; Injury; Pain

  MAUDE report 9785393 ↗
• InjuryMar 3, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD MESHES (BARD FLAT MESH) ON (B)(6) 2000, (B)(6) 2002 AND A BARD/DAVOL COMPOSITE MESH (COMPOSIX) ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2013 AND (B)(6) 2018 DUE TO THE DEFECT IN THE BARD MESH. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9780670 ↗
• InjuryFeb 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO THE (B)(6): PER THE INFORMATION PROVIDED POST IMPLANT (BARD FLAT MESH) THE PATIENT EXPERIENCED, SEVERE CHRONIC PELVIC AND VAGINAL PAIN, BOWEL DYSFUNCTION. THE INFORMATION STATES THAT THE PATIENT UNDERWENT REMOVAL OF THE SACROCOLPOPEXY MESH AFTER THE MDT.

  Patient problems: Pain

  MAUDE report 9675852 ↗
• InjurySep 18, 2019Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2013, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL KUGEL HERNIA PATCH (DEVICE#1). IT IS ALLEGED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH (DEVICE #2). AS ALLEGED, ON (B)(6) 2015, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE KUGEL HERNIA PATCH (DEVICE #1) AND BARD MESH (DEVICE #2) AND UNDERWENT REVISION SURGERY AND IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE KUGEL HERNIA PATCH AND BARD MESH. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

  Patient problems: Disability; Fibrosis; Hernia; Injury; Nerve Damage; Neuralgia; Pain; Scar Tissue

  MAUDE report 9084774 ↗
• InjuryAug 22, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD [FLAT] MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD [FLAT] MESH. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 8920611 ↗
• InjuryAug 14, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH (DEVICE #1 AND DEVICE #2) ON (B)(6) 2007 AND (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) BARD MESH(DEVICE #1 AND DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

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

  MAUDE report 8894540 ↗
• InjuryAug 1, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL BARD MESH. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 8852042 ↗
• InjuryJul 3, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." ATTORNEY ALLEGES UNSPECIFIED INJURIES ON (B)(6) 2010.

  Patient problems: Disability; Injury; Necrosis; Pain; Purulent Discharge; Scar Tissue; Unspecified Infection

  MAUDE report 8759945 ↗
• InjuryJul 1, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD MESH. IT IS ALLEGED THAT ON (B)(6) 2013, THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

  Patient problems: Disability; Fibrosis; Hernia; Inflammation; Injury; Pain

  MAUDE report 8750136 ↗
• InjuryJun 27, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, MEDICAL RECORDS & PRODUCT ID PAGE: ON (B)(6) 2000: THE PATIENT WAS DIAGNOSED WITH VAGINAL PROLAPSE, URINARY INCONTINENCE AND UNDERWENT AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL FLAT MESH. ON (B)(6) 2001: THE PATIENT WAS DIAGNOSED WITH VAGINAL PROLAPSE AND UNDERWENT A REVISION PROCEDURE, ANTERIOR COLPORRHAPHY, ANTERIOR REPAIR, LAPAROTOMY AND LYSIS OF ADHESIONS. ON (B)(6) 2016: THE PATIENT WAS DIAGNOSED WITH A COLOVAGINAL FISTULA AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH TAKEDOWN AND REPAIR OF COLOVAGINAL FISTULA, SIGMOID COLON, SMALL BOWEL RESECTION, REMOVAL OF THE BARD/DAVOL FLAT MESH, REPAIR OF INCARCERATED HERNIA AND AN INCIDENTAL APPENDECTOMY.

  Patient problems: Adhesion(s); Fistula; Prolapse

  MAUDE report 8741441 ↗
• InjuryJun 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH FOR THE REPAIR OF PELVIC PROLAPSE OF THE INTESTINES. SINCE THE PLACEMENT OF THE MESH IT IS ALLEGED THAT THE PATIENT HAS BEEN DISABLED DUE TO CHRONIC PAIN AND INFLAMMATION. IN 2018 IT IS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL EXPLANT OF THE MESH HOWEVER, AS REPORTED THE COMPLICATIONS ARE BECOMING "MORE AND MORE SERIOUS AND A COMPLETE REMOVAL IS NECESSARY."

  Patient problems: Disability; Inflammation; Pain

  MAUDE report 8719428 ↗
• InjuryJun 19, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, MEDICAL RECORDS & PRODUCT ID PAGE: ON (B)(6) 2013 THE PATIENT WAS DIAGNOSED WITH A VAGINAL VAULT PROLAPSE, INCLUSION CYST AND UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL FLAT MESH AND EXCISION OF INCLUSION CYST. PER THE OPERATIVE REPORT DETAILS, "THE MESH (DAVOL FLAT) WAS TAILORED TO COVER THE CUFF. ONCE DONE, IT WAS SECURED TO THE CUFF USING ETHIBOND SUTURES. ATTENTION WAS THEN PLACED TO THE SACRAL PROMONTORY. THE RETROPERITONEUM WAS THEN INCISED TO MAKE A TUNNEL TO CLOSE OVER THE MESH. ONCE THIS WAS DONE, THE MESH (DAVOL FLAT)WAS TENSIONED APPROPRIATELY. THE AUTOSUTURE TACKER WAS USED TO FIX 2 TITANIUM HELICAL FASTENERS TO THE SACRAL PROMONTORY." ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 8713184 ↗