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 2016-10-20 for UPSYLON? Y MESH KIT M0068318220 manufactured by Boston Scientific - Marlborough.
[58017739]
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 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
[58017740]
It was reported to boston scientific corporation that an upsylon y-mesh kit was implanted during a lap assisted sacrocolpopexy (non-robotic) procedure. According to the complainant, 3 months post procedure, the patient returned with recurrent prolapse and it was found that the sacral piece of the mesh tore off from the anterior and posterior pieces at the connection point. Revision was done using a polyform synthetic mesh in (b)(6) 2016 with no issues, and the patient is reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-03095 |
| MDR Report Key | 6045962 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-20 |
| Date of Report | 2016-09-26 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2016-10-20 |
| 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 | 2016-10-20 |
| Model Number | M0068318220 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Required No Informationntervention | 2016-10-20 |