BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068502110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Injury (2348); No Code Available (3191)
|
Event Date 04/29/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
(date of event): date of event was approximated to (b)(6) 2015 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an advantage fit system was implanted into the patient on (b)(6) 2015.As reported by the patient's attorney, the patient underwent a revision surgery on (b)(6) 2015 for posterior division of the tape.The tape had gripped excessively on the soft tissues causing the voiding dysfunction.Boston scientific has been unable to obtain additional information regarding the event to date.
|
|
Search Alerts/Recalls
|
|
|