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 2017-01-20 for UPSYLON? Y MESH KIT M0068318220 manufactured by Boston Scientific - Marlborough.
[65462286]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. 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
[65462287]
It was reported to boston scientific corporation that an upsylon y-mesh kit was used during sacrocolpopexy procedure on (b)(6) 2016. According to the complainant, during the procedure, when the mesh was tacked to the sacral promontory, the mesh is tore approximately 1 cm where the tack was placed. The physician gathered some tissue and put in a few more tacks to secure the mesh, and the procedure was completed with the original upsylon y-mesh device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-00028 |
| MDR Report Key | 6268832 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-28 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2017-01-20 |
| 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 | 2017-01-20 |
| Model Number | M0068318220 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2017-01-20 |