MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX SUP URETHRAL SUPPORT SYSTENM

Catalog Number 485013

Device Problem Defective Component (2292)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Internal Organ Perforation (1987); Urinary Frequency (2275); Hematuria (2558); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Tracking number: (b)(4).

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

Event Description

Per additional information received, the patient has experienced, erosion, extrusion, infection, urinary problems, bowel problems, organ perforation, fistulae, recurrence, bleeding, neuromuscular problems and vaginal scarring.

Event Description

Per additional information received, the patient has experienced urethrovaginal fistula, blood-tinged urine (hematuria), sling migration to bladder (foreign body in patient), suprapubic/pelvic pain, urinary frequency, vaginal bleeding, bladder/urethral erosion, bladder neck/wall perforation (organ perforation), small stones surrounding mesh (calcification), blood loss, urinary urgency, urinary incontinence, discomfort, recurrent infections, and required non-surgical and additional surgical interventions.

Manufacturer Narrative

H11:section a through f - 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.

• Brand Name: URETEX SUP URETHRAL SUPPORT SYSTENM
• Manufacturer (Section D): SOFRADIM PRODUCTION; trevoux F-016 00; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-016 00
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5371033
• MDR Text Key: 291725100
• Report Number: 1018233-2013-00392
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2008
• Device Catalogue Number: 485013
• Device Lot Number: C23076SUP
• 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: 01/05/2016
• Distributor Facility Aware Date: 01/05/2016
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2016
• Initial Date Manufacturer Received: 01/21/2013
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: 01/21/2013; 01/05/2016
• Supplement Dates FDA Received: 01/02/2014; 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DERMAL ALLOGRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female