MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-09 for UPSYLON Y MESH KIT 08714729839217 M0068318200 manufactured by Boston Scientific Corporation.
| Report Number | MW5087983 |
| MDR Report Key | 8776783 |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-07 |
| Date of Event | 2016-12-22 |
| Date Added to Maude | 2019-07-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UPSYLON Y MESH KIT |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2019-07-09 |
| Model Number | 08714729839217 |
| Catalog Number | M0068318200 |
| Lot Number | C003036 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-07-09 |