BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068505000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 08/03/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Initial reporter name and address: this event was reported to boston scientific corporation legal by the patient's legal representation.The implanting surgeon is (b)(6).(b)(4).
|
|
Event Description
|
It was reported to boston scientific corporation that an obtryx system - halo was implanted during a vaginal sling implant and cystourethroscopy procedures performed on (b)(6) 2016 to treat a patient with cystocele and stress urinary incontinence.The patient was taken to the recovery room in good condition.As reported by the patient's attorney, the patient experienced an unspecified injury.
|
|
Search Alerts/Recalls
|
|
|