ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
|
Back to Search Results |
|
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Pain (1994); Not Applicable (3189)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? product code and lot #? what is physician¿s opinion as to the etiology of or contributing factors to this event? were any concomitant procedures performed? onset date/time of the pain from surgery? location and character of the pain? what medical intervention was given for the pain management? results? date and results of partial mesh removal? what is the patient's current status?.
|
|
Event Description
|
It was reported that the patient underwent gynecological procedure on an unknown date and mesh was implanted.Following the procedure, the patient experienced pain and discomfort, and underwent removal of vaginal portion of mesh.Additional information has been requested.
|
|
Search Alerts/Recalls
|
|
|