BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
|
Back to Search Results |
|
Model Number M0068502000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430)
|
Event Date 05/26/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient identifier: (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 a uphold lite implant was implanted into the patient on (b)(6) 2015 and a advantage implant was implanted into the patient on (b)(6) 2015.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; groin pain; anal pain; rect pain; thi pain; diff bowel; incont not pres; rec incont; aggrav incont; psych.
|
|
Search Alerts/Recalls
|
|
|