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Catalog Number 0112640
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Hematuria (2558)
Event Date 05/27/2014
Event Type  Injury  
Manufacturer Narrative
Based on the medical records provided, the non-bard davol mesh as well as the bard flat mesh were implanted very close to each other anatomically, due to this, it is unclear at this time to what extent if any the bard flat mesh may have caused or contributed to the issues experienced post implant. It is also unclear if the bard flat mesh was resected in the (b)(6) 2014 procedure as the operative detail indicates the cystocele repair which used the bard flat mesh was well supported. A manufacturing review was performed which found no anomalies noted during the manufacturing process of the device. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any of the patient's post op complications. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2007 - the patient was diagnosed with anterior vaginal prolapse (cystocele) and stress urinary incontinence. The patient underwent a cystocele repair with implant of a davol flat mesh and repair of the urinary incontinence with placement of a non-bard davol tvt sling. On (b)(6) 2007 - the patient had a post op office visit. It appeared that the cystocele was well reduced and there is no evidence of urethral hypermobility. There is concern that the patient might have a uti. The physician felt she should treat her empirically (prior to cultures) with antibiotics and has sent her urine for culture (later result is negative). Patient started on some estrace cream for vaginal tenderness that should improve with time. Per md notes the recurrent incontinence is what seems to be the failure of her tvt. On (b)(6) 2007 - the patient had a post op office visit. Physical exam shows good support with no evidence of prolapse and her urine specimen was unremarkable. Per the md: the patient's urinary control has significantly improved. The main problem is she has got a significant amount of pain and discomfort from the mesh (flat) as well as from the sling and she has an area that is very tender just behind the urethral meatus, but the rest of the exam reveals satisfactory support. No infection, no abscess. On (b)(6) 2008 - patient had an md visit. On exam, a well-healed anterior vaginal wall. No evidence of vaginal atrophy. No significant urethral hypermobility and no stress incontinence. Per md the protuberance the patient is feeling is believed to be a grade 2 rectocele. Patient is not symptomatic. Due to her line of work, patient was advised not to lift more than 25 lbs. On (b)(6) 2008 and (b)(6) 2009 - patient had md office exams with complaints of burning with urination and pinching in the urethra from prior surgery. Patient feels sensation of rubbing and gets blood streaks in her urine over the past months. On (b)(6) 2009 - the patient underwent a cystoscopy, bladder tumor biopsy and fulguration. On (b)(6) 2009 - the patient had office visits with complaints of pain in her lower urethra and has noticed blood when wiping. Patient also has intermittent cramping pain. Patient requested a note for her work, as her work has her lifting boxes which weigh between 50-60 lbs. On (b)(6) 2009 - the patient had an office visit. Since the patient's last office visit the patient received pelvic floor physiotherapy which helped some with her pain, however, the patient stopped going to therapy because of the continued required heavy lifting at her job. Patient stated that every time she lifts it feels like the mesh is pulling on and irritating her pelvic tissues. Patient feels her rectocele is getting more prominent. On (b)(6) 2011 - the patient had an md office visit with complaints of painful urination, frequent urination, urgency and lower abdominal pain. Patient states symptoms began a week ago. On (b)(6) 2014 - the patient had an md office visit. Patient complained of right pelvic pain and she believes this is from her bladder sling, and feels the sling rubbing against her bladder. On (b)(6) 2014 - the patient underwent a vagina mesh resection. Operative dictation notes "on physical exam she had cystocele in the introitus with posterior wall that was well supported, but no obvious problems. " of note a 3x3 piece of mesh was excised from the anterior vaginal wall. On (b)(6) 2014 - the patient had md office visits where she was diagnosed with uti and prescribed antibiotics. Patient also reporting experiencing sharp pain/ cramping to vulva and proceeds to right pelvic region following mesh removal. Patient also reports urgency and frequency but this is chronic and has been present for a while. Per md notes " i found a note from 2003 that described almost this same "debilitating rlq pain" as a chronic condition and this was long before the urology sling 2007. ".
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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
steven figueroa
100 crossings blvd.
warwick, RI 02886
MDR Report Key6456146
MDR Text Key71587574
Report Number1213643-2017-00203
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2010
Device Catalogue Number0112640
Device Lot Number43IPD011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2005
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: 04/04/2017 Patient Sequence Number: 1