SOFRADIM PRODUCTION UNKNOWN URETEX MESH PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number UNKNOWN URETEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Injury (2348)
|
Event Date 02/26/2004 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Since the lot number was not provided, this information cannot be determined.
|
|
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 mesh vaginal tape procedure and vaginal hysterectomy and tension-free vaginal tape procedure.Pre-op diagnosis: stress urinary incontinence and menorrhagia, leiomyomas of the uterus, and anemia.Post-op diagnosis: stress urinary incontinence and menorrhagia, leiomyomas of the uterus, and anemia.
|
|
Search Alerts/Recalls
|
|
|