MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN URETEX TRANSOBTURATOR MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Discharge (2225); Injury (2348); No Code Available (3191)

Event Date 11/16/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Patient underwent operation on (b)(6) 2007 for status post mid suburethral synthetic uretex t-o sling with extrusion of mesh and chronic discharge and drainage secondary to #1.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, additional implant surgery: (b)(6) 2006: underwent examination under anesthesia, mild sub-urethral trans-obturator uretex sling and cystoscopy for recurrent stress urinary incontinence, mixed incontinence with detrusor instability, failed previous retropubic/suprapubic pelvilace sling, mild intrinsic sphincter deficiency under general anesthesia.Mesh revision surgery: (b)(6) 2007: underwent exam under anesthesia, revision of mid sub-urethral sling, incision and cystoscopy evaluation for extrusion of uretex mesh, chronic discharge and drainage secondary to extrusion.Patient developed vaginal discharge, small extrusion of mesh, recurrent stress urinary incontinence secondary to equivocal isd/stress incontinence.In office mesh trimming on (b)(6) 2007.Interventional surgery - coaptite injection: (b)(6) 2016: underwent exam under anesthesia, cystoscopy with peri-urethral bulking injections of coaptite to augment previous tot sling under general- lma.

• Brand Name: UNKNOWN URETEX TRANSOBTURATOR MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6104258
• MDR Text Key: 59966420
• Report Number: 9615742-2016-00166
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR