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 2018-01-31 for UPSYLON? Y MESH KIT M0068318220 831-820 manufactured by Boston Scientific - Marlborough.
[98974920]
The lot number does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined, however, it was reported that the device was not used past expiry date. The complainant indicated that the device is implanted and will not 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
[98974921]
It was reported to boston scientific corporation that an upsylon y-mesh was implanted during a sacrocolpopexy procedure. According to the complainant, during the procedure, the mesh tore down the midline of the sacral tail. All other information is unknown. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00088 |
| MDR Report Key | 7232715 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-05 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2017-07-15 |
| Date Added to Maude | 2018-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | PROXY BIOMEDICAL LIMITED |
| Manufacturer Street | COILLEACH SPIDDAL |
| Manufacturer City | GALWAY |
| 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 | 2018-01-31 |
| Model Number | M0068318220 |
| Catalog Number | 831-820 |
| Lot Number | C003580 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-31 |