BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068317080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/18/2008 |
Event Type
Injury
|
Manufacturer Narrative
|
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2008, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.
|
|
Event Description
|
Note: this manufacturer report pertains to the first of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-02829 for the associated device.It was reported to boston scientific corporation that an uphold vaginal support system and obtryx system - halo device was implanted into the patient during anterior apical repair and a transobturator mid-urethral sling with a cystoscopy procedure performed on (b)(6) 2008, for the treatment of pelvic prolapse and stress urinary incontinence.A third-degree uterine prolapse with a fourth-degree cystocele, a straightened urethrovesical angle, and a normal-sized uterus are among the findings of the procedure.There was no evidence of an adnexal mass.Furthermore, the patient tolerated the procedure well and was transported to the recovery area in a satisfactory condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
|
|
Search Alerts/Recalls
|
|
|