• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 0117840
Device Problem Defective Device (2588)
Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120)
Event Date 08/31/2016
Event Type  Injury  
Manufacturer Narrative
Based on the information received, the patient experienced pelvic pain, dyspareunia post implant and underwent additional surgery for partial removal of the bard ptfe mesh. Subsequent follow-up showed no evidence of mesh and recurrent adhesions in the vagina. The explanted mesh was not returned to the manufacturer for evaluation. Based on the medical records received, there is no way to determine whether the bard ptfe mesh may have caused or contributed to the patient¿s problems experienced due to the patients extensive medical/surgical history and the limited clinical information provided. Summary will be updated if/when additional information is received. The instructions-for-use supplied with the device lists adhesions as a possible complication. In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " should additional information be provided a supplemental emdr will be submitted.
Event Description
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 fistula or inflammatory changes. (b)(6) 2014 - the patient presented with urinary tract infection due to of escherichia coli and was treated with augmentin for 7 days. (b)(6) 2014 - the ct scan with rectal contrast showed possible mass versus a sponge (possible mesh) in the pelvis from previous pelvic surgery. A retrograde pyelogram ruled out ureteroenteric fistula. (b)(6) 2014 - an mri pelvis w/contrast scheduled due to pelvic pain, stool incontinence showed no remarkable findings. (b)(6) 2015 and (b)(6) 2016 - the patient had hospital visits due to persistent anal incontinence, dyspareunia, vaginal pain; vaginal examination showed severe atrophy. The mesh could be easily palpated through posterior wall, without erosion or exposure noted. (b)(6) 2016 - endo-anal us demonstrated normal findings. The patient wanted to have the mesh excised due to persistent pain in the posterior wall which was scheduled on (b)(6)2016. (b)(6) 2016 and (b)(6) 2016 - the patient had presented with dyspareunia, vaginal pain, and fecal incontinence; mesh excision was desired due to persistent pain in the posterior wall. (b)(6) 2016 - the patient underwent excision of the bard ptfe mesh. Per the operative details, ¿the obvious filmy adhesions to the most apical aspect of the vaginal cuff. These adhesions were taken down. The endopelvic fascia was accessed; the mesh (ptfe) with multiple sutures were identified at this point. At the time of the dissection, we dissected each individual suture and removed it. We then extended our dissection cephalad to identify the rest of the mesh. The mesh was located proximally, close to the apex of the vaginal cuff. Decision was made to stop the section about 3 cm from the apex since access was very difficult. We removed about 2 cm of mesh. ¿ the pathology report stated one piece of synthetic mesh (1. 0 x 0. 3 x 0. 1 cm) and 2 pieces of surgical sutures were received; one of the sutures had adhesions with the mesh segment. (b)(6) 2016 - the patient reported having fecal incontinence and would like to be evaluated for sacral nerve stimulation. Anorectal inspection showed a slightly patulous anal verge. On digital rectal exam, there seemed to be adequate sphincter squeeze pressure. The patient underwent sacral nerve stimulation on (b)(6) 2016. Post-op assessment indicated failed peripheral nerve stimulation, possibly from a mechanical failure stimulation device. The procedure was rescheduled on (b)(6) 2016, which was successful. (b)(6) 2017 - the patient reported to the clinic with vaginal pain and dyspareunia on (b)(6)2017. The pelvic exam performed showed that the high tone pelvic disorder; the vagina was fully patent with no evidence of mesh and recurrent adhesions. Attorney alleges unspecified adverse patient outcomes associated with the use of bard/davol device. It is also alleged that the device was defective.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
MDR Report Key11023121
MDR Text Key222009304
Report Number1213643-2020-11237
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2012
Device Catalogue Number0117840
Device Lot NumberHURB3764
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1