BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number 831-708 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430)
|
Event Date 11/07/2012 |
Event Type
Injury
|
Event Description
|
It was reported to boston scientific corporation that a uphold was implanted into the patient on (b)(6) 2012.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; off vag dis; diff bowel; incont not pres; psych; oth pain: lower abdominal.Nonsurgical treatments: the patient was treated with pain medication: panadine forte for the treatment of: vaginal pain - generated by infection.Treatment duration: for length of infections.The patient was treated with psychological medication: pristiq for the treatment of: depression and anxiety over continuing gynaecological problems.Treatment duration: several years.The patient was treated with other medication (please specify): antibiotics for the treatment of: infections - causes thrush.Treatment duration: ongoing.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.The patient was treated with topical treatment (including oestrogen cream): suppository and creams for the treatment of: fungal infections.The patient was treated with other (please specify) for the treatment of: incontinence.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|