MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX SUPPORT PP KIT X1

Catalog Number URETEXSUP

Device Problem Material Erosion (1214)

Patient Problems Bruise/Contusion (1754); Deposits (1809); Erythema (1840); Micturition Urgency (1871); Unspecified Infection (1930); Internal Organ Perforation (1987); Urinary Frequency (2275); Prolapse (2475); Abdominal Distention (2601); Fluid Discharge (2686); Foreign Body In Patient (2687); Sexual Dysfunction (4510); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/29/2007

Event Type  Injury  

Manufacturer Narrative

Tracking number: (b)(4).

Event Description

Procedure type: urogynecological.According to the reporter: it was reported in the patient's medical records that as a result of having the product implanted, the patient experienced change in sexual desire or performance, "dryness with vaginal area,' leaking of urine with physical activity or standing, urinary incontinence etiology unknown, mixed incontinence, stress incontinence without intrinsic sphincter deficiency plus detrusor overactivity with reduced capacity and compliance, pap smear showing mild dysplasia with possible high risk cells present, urinary urgency, urgency incontinence, urinary incontinence, voiding every hour, nocturia 1 time per night, loss of urine prior to reaching toilet, symptomatic urinary stress incontinence.Patient had a tension-free vaginal tape suspension of the bladder - ((b)(6) 2010) , swelling, bruising, inflammation, and irritation over exit wound; serous fluid draining from left exit wound, erosion of tension-free vaginal tape, bladder foreign body-status post tension-free tape suspension of the bladder, cystoscopy, holmium laser vaporization of bladder foreign body, excision of bladder foreign body, overactive bladder symptoms, mild erythema at site of prior excision of eroded tape, bladder wall calcification at site of prior erosion of the sling, urinary incontinence-recurrent stress, bladder stones, urinalysis positive for wbc (no diagnosis or treatment in records provided) , and abdominal distention and bladder perforation.

Event Description

Per additional information received, the patient has experienced loss of consortium, dyspareunia, recurrent vaginal path with sexual activity, urinary retention, "must wear pads every day"."she and her husband have stopped trying to have intercourse due to her pain", unable to work while she had a catheter, "urine was oozing out of her incision from her surgical site", "bladder stones hooked themselves to the mesh", surgery to remove the mesh, and emotional distress and has disrupted her life.

Event Description

Per additional information received, the patient has experienced vaginal dryness.In 2010, urodynamics revealed stress incontinence and detrusor overactivity with reduced capacity and compliance.She complained of urgency, nocturia, urge incontinence, depression and continued to have abnormal pap smears.After trying anticholinergic medications, she underwent a second tension free vaginal tape suspension of the bladder for urinary stress incontinence in early december 2010.Soon after this implant, she had swelling, bruising and serous drainage from the left exit wound site and abdominal distention, which led to the discovery of erosion of the tape just left of the trigone during cystoscopy and evidence of urinary extravasation, or bladder perforation.She underwent holmium laser vaporization of a bladder foreign body in late december 2010, in which a 2mm knuckle of the suspension tape was found protruding above the bladder mucosa on the left-hand side.After this revision, she continued to have some urgency and overactive bladder symptoms.A second excision of a bladder foreign body was performed in march 2011, in which the mesh from the tension-free vaginal tape suspension eroded approximately 3mm of the bladder mucosa anterior to the trigone.In 2012, she continued to complain of stress urinary incontinence.Cystoscopy found that she had moderate hypermobility of the urethra, mild prolapse of the bladder and rectum during the valsalva maneuver into the vagina and multiple bladder calcifications.In (b)(6) 2012 she underwent a partial cystectomy and excision of eroded sling and bladder calcifications, placement of a suprapubic catheter, and placement of a left ureteral stent due to recurrence of bladder calcifications and an eroded urethral sling.Calcifications were seen attached to the bladder mucosa at the mid-trigone, anterior to the left ureteral orifice, and the left bladder neck.The left ureteral orifice was displaced laterally, appearing to be surgically altered in some sense, and was cannulated with a ureteral stent.The calcifications, erosions, and sling material were excised.

• Brand Name: URETEX SUPPORT PP KIT X1
• Type of Device: URETEX SUPPORT
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00; FR F-01600
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5274900
• MDR Text Key: 291708294
• Report Number: 1018233-2013-00342
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2015,11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URETEXSUP
• Device Lot Number: SHA00338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2015
• Distributor Facility Aware Date: 11/11/2015
• Device Age: 5 MO
• Date Report to Manufacturer: 12/08/2015
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG