MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-09 for UPSYLON? Y MESH KIT M0068318220 manufactured by Boston Scientific - Marlborough.
[4226387]
It was reported to boston scientific corporation that an upsylon y-mesh kit was used on a sacrocolpopexy procedure on (b)(6) 2014. According to the complainant, during the procedure, when the physician was tacking the mesh to the sacral promontory using the prothe device, the mesh tore under tension at the sacral portion but it did not tear into two pieces. Prior to implantation, a part of the mesh was trimmed by the physician. She used the trimmed piece to suture the torn mesh. There were no patient complications reported as a result of this event. 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
[11821021]
The exact age of the patient is unknown, however, it was reported the patient was over 18 years. 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 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
| Report Number | 3005099803-2014-01642 |
| MDR Report Key | 3736200 |
| Report Source | 05,07 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-04-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. INGRID MATTE |
| 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 | 2014-04-09 |
| 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 | 2014-04-09 |