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 Problems
Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Post Operative Wound Infection (2446); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
|
Event Date 12/17/2012 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(6) the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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 uphold was implanted on (b)(6) 2012.The patient experienced complications and further surgery.Patient symptoms include: vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2012 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: infection causing arterial bleed from surgery site.
|
|
Search Alerts/Recalls
|
|
|