MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-28 for UPSYLON Y MESH KIT manufactured by Boston Scientific Corporation.
[140118423]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The voluntary user medwatch number is mw5083911. The device is not expected to be returned for evaluation; 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.
Patient Sequence No: 1, Text Type: N, H10
[140118424]
It was reported to boston scientific corporation that an upsylon y-mesh device was implanted for treatment of bladder prolapse during a prolapse repair procedure performed on (b)(6) 2018. According to the complainant, after the procedure, the patient experienced severe pain in her lower abdomen. After multiple doctor's visits, a surgeon told the patient that the mesh had to be removed. Subsequently, the mesh was removed from the patient on (b)(6) 2019. Reportedly, the patient needs to have another surgery to correct her prolapsed bladder and rectocele after healing from the mesh removal procedure. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01399 |
| MDR Report Key | 8458818 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | PROXY BIOMEDICAL |
| Manufacturer Street | COILLEACH |
| Manufacturer City | SPIDDAL, CO GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPSYLON Y MESH KIT |
| Generic Name | GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES |
| Product Code | OHD |
| Date Received | 2019-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-28 |