Bard 0117840Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741031083), received between Mar 28, 2017 and Dec 16, 2020 — classified as 11 injuries.

The most frequently reported specific device problem is “Defective Device” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2020Defective Device; Defective Device

  PER INFORMATION PROVIDED BY THE ATTORNEY AND MEDICAL RECORDS: (B)(6) 2007 - PHYSICAL EXAMINATION ON (B)(6) 2007 REVEALED A GRADE 3 RECTOCELE, GRADE 2 ENTEROCELE, GRADE 1-2 CYSTOCELE. (B)(6) 2007 - A(B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF POST HYSTERECTOMY VAGINAL WALL PROLAPSE AND MIXED URINARY INCONTINENCE AND UNDERWENT CIRCUMFERENTIAL ABDOMINOPLASTY, ABDOMINAL SACRAL COLPOPEXY WITH IMPLANT OF BARD/DAVOL PTFE MESH, COMBINED ANTERIOR AND POSTERIOR REPAIR, SYNTHETIC PUBOVAGINAL SLING AND CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. PER THE OPERATIVE REPORT DETAILS, TWO SEPARATE PIECES OF TEFLON MESH (BARD PTFE MESH) WERE USED AND SECURED ONE TO THE ANTERIOR AND ONE TO THE POSTERIOR ASPECT OF THE VAGINAL VAULT USING MULTIPLE INTERRUPTED NON-BARD/DAVOL ETHIBOND SUTURES. THE TWO PIECES OF THE MESH WERE SECURED TOGETHER. THE MESH WAS ATTACHED TO THE SACRAL PROMONTORY AND EXCESS MESH WAS TRIMMED. SUBSEQUENTLY, ANTERIOR COLPORRHAPHY AND POSTERIOR COLPOPERINEORRHAPHY PROCEDURES WERE PERFORMED. CYSTOSCOPY CONFIRMED PATENCY OF THE BLADDER. (B)(6) 2014 - ABOUT 7 YEARS LATER, THE PATIENT HAD COMPLAINTS OF FECAL INCONTINENCE; A COLONOSCOPY SHOWED NO DEFINITE ENDOSCOPIC EVIDENCE OF FI

  Patient problems: Incontinence; Pain; Urinary Tract Infection

  MAUDE report 11023121 ↗
• InjuryMar 12, 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) 2007. 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: Abdominal Pain; Adhesion(s); Injury; Unspecified Infection

  MAUDE report 9823420 ↗
• InjuryDec 6, 2018Defective Device; Defective Device

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, IMPLANT OP REPORT & PRODUCT ID PAGE. ON (B)(6) 2005 THE PATIENT WAS DIAGNOSED WITH VAGINAL WALL PROLAPSE, PELVIC PAIN, MIXED URINARY INCONTINENCE AND UNDERWENT AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL PTFE MESH, BILAT SALPINGO-OOPHORECTOMY, COMBINED ANTERIOR/POSTERIOR REPAIR, IMPLANT OF A NON DAVOL URETEX PUBOVAGINAL SLING FOLLOWED BY CYSTOSCOPY AND SUPRAPUBIC CATHETER PLACEMENT. PER THE IMPLANT OPERATIVE REPORT DETAILS, "THE PERITONEUM WAS DISSECTED OFF OF THE VAGINAL APEX. WE THEN PLACED TWO SEPARATE PIECES OF TEFLON MESH, ONE POSTERIORLY AND ONE ANTERIORLY TO PROVIDE SUPPORT TO THE VAGINAL APEX. WE THEN DISSECTED LATERALLY TO THE RECTUM AND SECURED THE MESH TOT HE SACRUM." ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 8140095 ↗
• InjuryJul 12, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  AS REPORTED BY THE PATIENT'S ATTORNEY, IMPLANT OP REPORT & IMPLANT TRACKING LOG: ON (B)(6) 2006, THE PATIENT WAS DIAGNOSED WITH VAGINAL WALL PROLAPSE, MIXED URINARY INCONTINENCE AND UNDERWENT AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL PTFE MESH, COMBINED ANTERIOR-POSTERIOR REPAIR, IMPLANT OF A NON-BARD/DAVOL SYNTHETIC "URETEX" PUBOVAGINAL SLING AND INSERTION OF A SUPRAPUBIC CATHETER. PER THE IMPLANT OPERATIVE REPORT DETAILS, "WE THEN PLACED TWO PIECES OF TEFLON MESH (PTFE), ONE TO THE ANTERIOR ASPECT OF THE VAGINA AND ONE TO THE POSTERIOR ASPECT. THE TWO PIECES OF THE MESH WERE SECURED TO THE VAGINAL APEX WITH ETHIBOND SUTURE AND THE TWO PIECES TO THE MESH WERE SECURED TOGETHER. WE THEN ATTACHED THE MESH TO THE SACRAL PROMONTORY USING ETHIBOND SUTURE." ON (B)(6) 2012, THE PATIENT UNDERWENT CYSTOSCOPY WHICH IS NOTED TO HAVE BEEN "UNEVENTFUL." OFFICE VISIT NOTES INDICATE THE PATIENT TO HAVE EXPERIENCED BLOOD IN THE URINE ALONG WITH OCCASIONAL LEAKAGE OF URINE AFTER COUGHING AS WELL AS AFTER INITIAL URINATION. PATIENT TREATED FOR A UTI. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information; Urinary Tract Infection

  MAUDE report 7683753 ↗
• InjuryJul 12, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  AS REPORTED BY THE PATIENT'S ATTORNEY, IMPLANT OPERATIVE REPORT & IMPLANT TRACKING LOG: ON (B)(6) 2007 - THE PATIENT WAS DIAGNOSED WITH VAGINAL VAULT PROLAPSE MIXED URINARY INCONTINENCE AND UNDERWENT AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL PTFE MESH, COMBINED ANTERIOR-POSTERIOR REPAIR, IMPLANT OF A NON-BARD/DAVOL SYNTHETIC "URETEX" PUBOVAGINAL SLING AND INSERTION OF A SUPRAPUBIC CATHETER. PER THE IMPLANT OP REPORT DETAILS, "WE THEN PLACED TWO SEPARATE PIECES OF TEFLON MESH, ONE IN THE ANTERIOR AND ONE IN THE POSTERIOR ASPECT OF THE VAGINAL VAULT. THE TWO PIECES OF MESH WERE SECURED TOGETHER. ON (B)(6) 2007 - THE PATIENT HAD AN MD OFFICE VISIT WITH COMPLAINTS OF MILD DYSURIA WITH URGENCY WHEN EMPTY. SHE ALSO COMPLAINED OF VAGINAL CRAMPING THAT OCCURS 3-4 TIMES WEEKLY WITH DYSPAREUNIA AND RIGHT FLANK FULLNESS. PATIENT HAD A URINE CULTURE PERFORMED WITH NO RESULTS PROVIDED. ON (B)(6) 2009 - THE PATIENT COMPLAINED OF HAVING TO CHANGE POSITIONS TO URINATE AND HER VAGINAL AREA WAS HURTING. SHE REPORTED SHE FELT SOMETHING LIKE A SUTURE MATERIAL, SHE TUGGED ON IT AND IT MADE HER FEEL SICK TO HER STOMACH. PATIENT COMPLAINED OF PAIN IN LOWER BACK AND LEGS WITH URINARY FREQUENCY AN

  Patient problems: Pain; Urinary Frequency / Polyuria

  MAUDE report 7683286 ↗
• InjuryJun 20, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY, IMPLANT OPERATIVE REPORT AND IMPLANT TRACKING LOG ALLEGE THE FOLLOWING: ON (B)(6) 2006 - THE PATIENT WAS DIAGNOSED WITH POST-HYSTERECTOMY VAGINAL VAULT PROLAPSE, MIXED URINARY INCONTINENCE AND UNDERWENT AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL PTFE MESH (DEVICE 1), COMBINED ANTERIOR/POSTERIOR REPAIR, IMPLANT OF A NON DAVOL "URETEX" PUBOVAGINAL SLING FOLLOWED BY CYSTOSCOPY AND SUPRAPUBIC CATHETER PLACEMENT. THE PATIENT'S ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 7622644 ↗
• InjuryNov 10, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008 - THE PATIENT WAS DIAGNOSED WITH POST-HYSTERECTOMY VAGINAL VAULT PROLAPSE, MIXED URINARY INCONTINENCE AND PELVIC PAIN. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD PTFE MESH, BILATERAL SALPINGO-OOPHORECTOMY, COMBINED ANTERIOR/POSTERIOR REPAIR, IMPLANT OF A NON-DAVOL URETEX PUBOVAGINAL SLING FOLLOWED BY CYSTOSCOPY AND SUPRAPUBIC CATHETER PLACEMENT. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED UNSPECIFIED ADVERSE PATIENT OUTCOME ASSOCIATED TO USE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 7022803 ↗
• InjuryJun 26, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2005 - THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH IMPLANT OF A BARD/DAVOL "MARLEX PTFE MESH" IN HER PELVIC AREA. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED PAIN, PAIN AND SUFFERING, DISABILITY, IMPAIRMENT AND INABILITY TO ENGAGE IN NECESSARY ACTIVITIES.

  Patient problems: Disability; Pain

  MAUDE report 6667893 ↗
• InjuryMar 28, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENTS ATTORNEY: ON (B)(6) 2005 - THE PATIENT WAS DIAGNOSED WITH A POST OBSTRUCTIVE VAGINAL VAULT PROLAPSE, MIXED URINARY INCONTINENCE AND PELVIC PAIN. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY, COMBINED ANTERIOR/POSTERIOR REPAIR WITH IMPLANT OF A BARD PTFE MESH, BILATERAL SALPINGO-OOPHORECTOMY, IMPLANT OF A NON DAVOL SUBURETHRAL SLING FOLLOWED BY CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN ADVERSE OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 6438780 ↗
• InjuryMar 28, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - THE PATIENT WAS DIAGNOSED WITH A POST HYSTERECTOMY VAGINAL VAULT PROLAPSE WITH MIXED URINARY INCONTINENCE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY, COMBINED ANTERIOR AND POSTERIOR REPAIR USING A DAVOL PTFE MESH, IMPLANT OF A NON-DAVOL SUBURETHRAL MESH SLING AND CYSTOSCOPIC SUPRAPUBIC CATHETER PLACEMENT. ON (B)(6) 2007 AND (B)(6) 2008 - THE PATIENT HAD AN MD OFFICE VISITS WITH COMPLAINTS OF AN INCREASE OF VAGINAL DISCHARGE AND URINARY INCONTINENCE. THE PATIENT WAS PRESCRIBED AN ORAL ANTIFUNGAL MEDICATION FOR A VAGINAL YEAST INFECTION AND REFERRED TO CONSULT WITH ANOTHER UROLOGIST REGARDING REPORTED INCONTINENCE. ON (B)(6) 2008 - THE PATIENT WAS DESCRIBED WITH VOIDING DYSFUNCTION, URINARY INCONTINENCE AND URETHRAL CYST. THE PATIENT UNDERWENT A CYSTOURETHROSCOPY, URETHRAL CYST RESECTION, CAUTERIZATION OF A BLEEDING BASE, SUBURETHRAL AND PERIURETHRAL EXPLORATION AND EXCISION OF SCAR TISSUE. ON (B)(6) 2011 - THE PATIENT HAD AN MD OFFICE EXAM WITH COMPLAINTS OF PAIN AT HER LEFT SIDE, "OVARY PAIN." ON (B)(6) 2012 - THE PATIENT HAD AN MD OFFICE EXAM WITH COMPLAINTS

  Patient problems: Abdominal Pain; Incontinence; Pain

  MAUDE report 6438777 ↗
• InjuryMar 28, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007 - THE PATIENT WAS DIAGNOSED WITH POST HYSTERECTOMY VAGINAL VAULT PROLAPSE AND MIXED URINARY INCONTINENCE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY, COMBINED ANTERIOR/POSTERIOR REPAIR WITH IMPLANT OF A BARD PTFE MESH, IMPLANT OF A NON-DAVOL SUBURETHRAL SLING FOLLOWED BY CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 6438730 ↗