Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problems
Erosion (1750); Incontinence (1928); Urinary Tract Infection (2120); Injury (2348)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
|
|
Event Description
|
It was reported by an attorney that the patient experienced stress urinary incontinence.It was reported that the patient underwent a gynecological procedure (b)(6) 2003 and an unknown mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
|
|
Manufacturer Narrative
|
Date sent to fda: 04/23/2020.Additional narrative: it was reported that the patient underwent a mesh removal on (b)(6) 2020 due to mesh sling exposure.It was reported that she experienced urinary tract infection, urinary incontinence and erosion.
|
|
Search Alerts/Recalls
|