MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-23 for UPSYLON Y MESH KIT M0068318220 72912 manufactured by Boston Scientific Corporation.
[133845667]
(b)(4). The complainant indicated that the device was disposed 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
[133845668]
It was reported to boston scientific corporation that an upsylon y-mesh kit device was used during a sacrocolpopexy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, during placement, the mesh tore but did not separate into pieces. Reportedly, the physician stretched the mesh to reach the sacrum but he did not expect the mesh to tear. The procedure was completed with a different 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 | 3005099803-2019-00171 |
| MDR Report Key | 8270339 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2018-12-31 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2019-01-23 |
| 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 | 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 | 2019-01-23 |
| Model Number | M0068318220 |
| Catalog Number | 72912 |
| Lot Number | C003725 |
| 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 | 2019-01-23 |