Xenform™ M0068302470Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729774198), received between May 4, 2017 and May 1, 2023 — classified as 23 injuries.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A ROBOTIC-ASSISTED LAPAROSCOPIC SACROCOLPOPEXY, LYSIS OF ADHESIONS, EXCISION OF EXPOSED MESH INTRAABDOMINALLY, REPAIR OF IMMEDIATELY RECOGNIZED RECTAL INJURY, PERITONEAL FLAP ADVANCEMENT AS AN INTERPOSING FLAP, AND PLACEMENT OF A BIOLOGIC INTERPOSING GRAFT FOR THE TREATMENT OF RECURRENT ENTEROCELE AND RECTOCELE STATUS POST-HISTORY OF TRANSVAGINAL SURGICAL PROCEDURE TO CORRECT PROLAPSE AND MESH EXPOSURE WITH ADHERENCE TO SMALL BOWEL INTRAABDOMINALLY PROCEDURES ON (B)(6) 2014. PRIOR TO PLACEMENT OF THE XENFORM, DURING POSTERIOR DISSECTION FOR THE PLACEMENT OF A NON-BSC Y-MESH, THE RECTAL WALL REPORTEDLY HAD A SMALL OPENING DURING THE DISSECTION PROCESS THAT WAS DETECTED RIGHT AWAY AND MEASURED LESS THAN 2 CM. A TWO-LAYER CLOSURE WAS THEN DECIDED TO PERFORM. A XENFORM WAS PLACED TO INTERPOSE BETWEEN THE ANTICIPATED PLACEMENT OF THE NON-BSC Y-MESH AND THE REPAIR OF THE RECTAL DEFECT. THE PATIENT TOLERATED THE PROCEDURE WELL; CONSEQUENTLY, SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSP

  Patient problems: Insufficient Information

  MAUDE report 16850577 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL HYSTERECTOMY + BILATERAL SALPINGO - OOPHORECTOMY + POSTERIOR REPAIR WITH XENFORM MESH PROCEDURE PERFORMED ON (B)(6) 2010 FOR THE TREATMENT OF UTEROVAGINAL PROLAPSE, CYSTOCELE RECTOCELE, POSTMENOPAUSAL BLEEDING AND URINARY INCONTINENCE. FINDINGS SHOWED UTEROVAGINAL PROLAPSE WITH LARGE MID - PORTION RECTOCELE AND CENTRAL DEFECT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16809953 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM AND XENFORM DEVICES WERE IMPLANTED INTO THE PATIENT DURING AN ANTERIOR COLPORRHAPHY, BILATERAL SS VAGINAL VAULT SUSPENSION/UTERINE SUSPENSION, RECTOCELE REPAIR, SLING REVISION, TENSION FREE VAGINAL TAPE SUBURETHRAL SLING WITH BS SYSTEM, PLACEMENT OF XENO GRAFT, ANAL SPHINCTEROPLASTY, BARTHOLIN CYSTECTOMY, SKIN BIOPSY, VAGINAL PACKING DUE TO EXTENSIVE DISSECTION AND OOZING. URETHRAL CYSTOSCOPY, FOLEY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015 TO TREAT MIDLINE CYSTOCELE, UTERINE PROLAPSE, RECTOCELE, URODYNAMIC STRESS URINARY INCONTINENCE, URINARY FREQUENCY AND URGENCY, FECAL INCONTINENCE, WEAKENED PELVIC TISSUE. ON (B)(6) 2015, THE PATIENT HAD REVISION OF SLING, URETHROLYSIS AND URETHROCYSTOSCOPY DUE TO IRRITATIVE OBSTRUCTIVE SYMPTOMS WITH URINARY RETENTION. POSTOPERATIVE DIAGNOSE REPORTED NO OBVIOUS URETHRAL BLOCKAGE FROM THE SLING. THE SLING APPEARED TO BE IN DISTAL URETHRAL PORTION OF URETHRA. DURING THE PROCEDURE, THE SLING WAS COMPLETELY FREED OFF FROM ITS ATTACHMENT TO THE URETHRA AND SURROUNDING SCA

  Patient problems: Scar Tissue; Urinary Retention

  MAUDE report 16384653 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM WAS IMPLANTED INTO THE PATIENT DURING SACROSPINOUS LIGAMENT FIXATION AND XENFORM PLACEMENT PROCEDURES PERFORMED ON (B)(6) 2015 TO TREAT PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, AFTER THE IMPLANTATION, THE PATIENT HAD EXPERIENCED AN UNKNOWN INJURY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Injury

  MAUDE report 11165601 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM AND A SOLYX SIS SYSTEM DEVICES WERE IMPLANTED DURING A XENFORM AND SOLYX PROCEDURE PERFORMED ON (B)(6) 2017 TO TREAT VAGINAL PROLAPSE. AFTER THE IMPLANTATION, THE PATIENT HAS SUFFERED FROM INJURIES AND DISABILITIES. THE PERSONAL INJURY ALLEGED TO HAVE BEEN SUFFERED BY THE PATIENT INCLUDES URINARY INCONTINENCE, URETHRAL EROSION/DAMAGE, REQUIREMENT FOR SUBSEQUENT PROCEDURES INCLUDING CYSTOSCOPIES, PUDENDAL BLOCKS, BOTOX INJECTIONS, EXCISION OF THE MESH FROM URETHRA, CHRONIC AND RELENTING PAIN TOGETHER WITH SYMPTOMS ARISING THEREFROM. REPORTEDLY, THE PATIENT HAD FURTHER PROCEDURES FOR TREATMENT AND MESH REMOVAL ON (B)(6) 2018.

  Patient problems: Disability; Discomfort; Erosion; Incontinence; No Code Available; Pain; Urinary Incontinence

  MAUDE report 10564790 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2007. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL XENFORM DEVICE ON (B)(6) 2008 FOR ENTEROCELE AND RECTOCELE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: No Code Available; Prolapse

  MAUDE report 9857614 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM DEVICE WAS IMPLANTED ON (B)(6) 2007 FOR REPAIR OF RECTOVAGINAL FISTULA. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT UNDERWENT ADDITIONAL PROCEDURES FOR FISTULA REPAIR ON (B)(6) 2010, (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010 DUE TO PERSISTENT RECTOVAGINAL FISTULA. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Fistula; No Code Available

  MAUDE report 9841965 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD RECURRENT CYSTOCELE AND RECURRENT VAGINAL VAULT PROLAPSE. SHE WAS IMPLANTED WITH A XENFORM DEVICE DURING A PROCEDURE FOR SACROSPINOUS LIGAMENT FIXATION, WITH CONCOMITANT REVISION OF A PREVIOUSLY-IMPLANTED NON-BSC MESH DEVICE. AS REPORTED BY THE PATIENT'S ATTORNEY, ON (B)(6) 2015, THE PATIENT UNDERWENT A PROCEDURE FOR CYSTOCELE REPAIR WITH NATIVE TISSUE DUE TO RECURRENT CYSTOCELE, RECURRENT INFECTIONS, AND INCOMPLETE BLADDER EMPTYING. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: No Code Available; Prolapse; Unspecified Infection; Urinary Retention

  MAUDE report 9834501 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT MATERIAL DEVICE WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION & CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(4) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE SUBJECT EXPERIENCED ATYPICAL VAGINAL DISCHARGE. SHE WAS TREATED WITH METROGEL VAGINAL CREAM AND THE EVENT RESOLVED ON (B)(6) 2017. THE INVESTIGATOR ASSESSED THE EVENT AS MILD IN SEVERITY, PELVIC FLOOR RELATED, POSSIBLY RELATED TO THE PROCEDURE, AND POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Prolapse

  MAUDE report 8374080 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM GRAFT MATERIAL WAS IMPLANTED DURING AN ANTERIOR/ POSTERIOR REPAIR WITH SACROSPINOUS LIGAMENT FIXATION USING XENFORM PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED GLUTEAL PAIN AND RECURRING PROLAPSE FOLLOWING THE USE OF XENFORM. THE PHYSICIAN DETERMINED THAT IT WAS MOST LIKELY THAT THE GLUTEAL PAIN WAS FROM THE SACROSPINOUS LIGAMENT SUTURE WHICH WAS COMMON POST OPERATION. HE ALSO TREATED THE PATIENT WITH AN ANESTHETIC BLOCK AND THE PAIN SETTLED TWO WEEKS LATER. REPORTEDLY, THE PROLAPSE WAS DETERMINED AS NOT BEING SIGNIFICANT ENOUGH TO WARRANT INTERVENTION AT THIS STAGE.

  Patient problems: Pain; Prolapse

  MAUDE report 8135884 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION, VAGINAL APPROACH HYSTEROPEXY, AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED BLOOD TRANSFUSION. THE EVENT RESOLVED ON (B)(6) 2015.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7975840 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING AN APICAL SUSPENSION AND CYSTOCELE REPAIR WITH XENFORM PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PATIENT WAS UNABLE TO VOID AFTER CATHETER REMOVAL. SHE WAS DISCHARGED WITH A FOLEY CATHETER AND HAD A POST-OPERATIVE INFECTION. THE CATHETER WAS THEN REMOVED AND SHE WAS PRESCRIBED WITH ANTIBIOTICS. NEVERTHELESS, THE REPAIR WAS NOTED TO BE HEALING WELL. THE EVENT OF URINARY RETENTION RESOLVED ON (B)(6) 2014. SHE HAS NO FEVERS AT PRESENT.

  Patient problems: Unspecified Infection; Urinary Retention; Urinary Tract Infection

  MAUDE report 7975770 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)64) 2015. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2015 AND THERE WERE NO SIGNS OF INFECTION. HOWEVER, IT WAS NOTED THAT THE PATIENT WAS TREATED FOR URINARY TRACT INFECTION ON AN UNKNOWN DATE. HER POST-VOID RESIDUAL URINE VOLUME WAS NORMAL BUT URINE WAS TO BE SENT FOR CULTURE TO CHECK FOR UTI RESOLUTION. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 7958996 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED SPONTANEOUS RECTAL PAIN OF MODERATE SEVERITY ON THE SAME OF THE PROCEDURE AFTER SHE WAS DISCHARGED. THIS EVENT WAS ASSESSED AS PROBABLY RELATED TO MUSCLE SPASM, AND MODERATE IN SEVERITY. SHE WAS THEN PRESCRIBED WITH DIAZEPAM, HYDROCODONE, DULCOLAX, AND CITRATE OF MAGNES. THE PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2014. ON VAGINAL AND RECTAL EXAM, THE PATIENT WAS TENDER ONLY AT THE RIGHT SACROSPINOUS LIGAMENT WITH PAIN REFERRING DOWN TO RECTAL AREA. THERE WERE NO AREAS OF INDURATION, NO ABSCESS, NO MESH EXPOSURE OR INFECTION AND NO SUTURE OR GRAFT MATERIAL IN RECTUM. SUTURE PLACEMENT AT SITE OF SACROSPINOUS LIGAMENT MAY HAVE IRRITATED NERVE CAUSING THE PAIN TO RECTAL AREA. ON (B)(6) 2014, SHE UNDERWENT A SURGERY TO RELEASE THE SUTURE AND THE EVENT OF RECTAL PAIN RESOLVED.

  Patient problems: Pain

  MAUDE report 7954493 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING RIGHT AND LEFT SACROSPINOUS LIGAMENT SUSPENSION AND CYSTOCELE REPAIR PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT PRESENTED WITH VAGINAL INFECTION. SHE WAS PRESCRIBED WITH CLINDAMYCIN VAGINAL CREAM AND THE EVENT RESOLVED ON (B)(6) 2016.

  Patient problems: Unspecified Infection

  MAUDE report 7885630 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION. SHE WAS TREATED WITH CIPRO AND URIBEL. THE EVENT RESOLVED ON (B)(6) 2015.

  Patient problems: Urinary Tract Infection

  MAUDE report 7012982 ↗
• InjurySep 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX DEVICE WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT EXPERIENCED A SUTURE EXPOSURE IN THE ANTERIOR VAGINA WITH ASSOCIATED SPONTANEOUS PAIN. THE SUTURE EXPOSURE AND THE PAIN RESOLVED ON (B)(6) 2015 BY CAUTERIZING THE GRANULATION TISSUE WITH SILVER NITRATE AND TRIMMING THE SUTURE.

  Patient problems: Erosion; Pain

  MAUDE report 6892844 ↗
• InjurySep 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSPAREUNIA. SHE WAS TREATED WITH PHYSICAL THERAPY AND THE EVENT HAS NOT YET RESOLVED. ADDITIONAL INFORMATION RECEIVED ON JULY 28, 2020. THE EVENT OF DYSPAREUNIA WAS PRESENT AT THE PATIENT'S BASELINE AND HAS NOT WORSENED IN FREQUENCY OR SEVERITY.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 6892552 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT EXPERIENCED FECAL INCONTINENCE. NO TREATMENT HAS BEEN GIVEN AND THE EVENT HAS NOT YET RESOLVED. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 27, 2017. THE EVENT OF FECAL INCONTINENCE WAS RESOLVED ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 11, 2018. THE CORRECT ONSET DATE FOR THE EVENT OF FECAL INCONTINENCE IS (B)(6) 2016.

  Patient problems: Incontinence

  MAUDE report 6871541 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION. SHE WAS TREATED WITH MACROBID AND THE EVENT RESOLVED ON (B)(6) 2014.

  Patient problems: Unspecified Infection

  MAUDE report 6866614 ↗
• InjuryAug 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION. SHE WAS TREATED WITH GENTAMYCIN AND THE EVENT RESOLVED ON (B)(6) 2015.

  Patient problems: Urinary Tract Infection

  MAUDE report 6822421 ↗
• InjuryJul 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM SOFT TISSUE REPAIR MATRIX DEVICE WAS IMPLANTED DURING A PELVIC FLOOR RECONSTRUCTION WITH XENFORM INCLUDING APICAL VAULT SUSPENSION AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT EXPERIENCED DIFFICULTY EMPTYING HER BLADDER. NO TREATMENT WAS GIVEN AND THE EVENT HAS NOT YET RESOLVED.

  Patient problems: Urinary Retention

  MAUDE report 6739242 ↗
• InjuryMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A XENFORM TISSUE REPAIR MATRIX WAS USED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT EXPERIENCED DYSURIA. THE PATIENT WAS TREATED WITH CIPROFLOXACIN AND THE EVENT RESOLVED ON (B)(6) 2017. THE INVESTIGATOR ASSESSED THE EVENT AS MODERATE IN SEVERITY, PELVIC FLOOR RELATED, POSSIBLY RELATED TO THE PROCEDURE, AND POSSIBLY RELATED TO THE DEVICE. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 AND (B)(6) 2018*** - ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ADVERSE EVENT OF BLADDER INFECTION. SHE WAS TREATED WITH AMPICILLIN AND THE EVENT HAS NOT RESOLVED OR RECOVERED. -THE PATIENT PRESENTED URINARY TRACT INFECTION ON (B)(6) 2015. SHE WAS TREATED WITH ANTIBIOTICS AND THE EVENT RESOLVED ON (B)(6) 2015. THE INVESTIGATOR ASSESSED THE EVENT AS MILD IN SEVERITY, PELVIC FLOOR RELATED, POSSIBLY RELATED TO THE PROCEDURE, AND POSSIBLY RELATED TO THE STUDY DEVICE.

  Patient problems: Dysuria; Unspecified Infection

  MAUDE report 6544417 ↗