Model Number UNK PELVICOL |
Device Problem
Extrusion (2934)
|
Patient Problem
Injury (2348)
|
Event Date 08/19/2004 |
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).
|
|
Event Description
|
Interventional surgery - coaptite injection: (b)(6) 2016: underwent exam under anesthesia, cystoscopy with peri-urethral bulking injections of coaptite to augment previous tot sling.
|
|
Manufacturer Narrative
|
Medtronic complaint report; (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 cysto scopy for recurrent stress urinary incontinence, mixed incontinence with detrusor instability, failed previous retropubic/suprapubic pelvilace sling, mild intrinsic sphincter deficiency under general anesthesia.
|
|
Search Alerts/Recalls
|