MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for BOSTON SCIENTIFIC RESOLUTION 360 CLIP M00521230 08714729875628 manufactured by Boston Scientific Corporation.
[136066573]
Clip failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083819 |
| MDR Report Key | 8315811 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-12-22 |
| Date Added to Maude | 2019-02-07 |
| 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 | RISK MANAGER |
| 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 | BOSTON SCIENTIFIC RESOLUTION 360 CLIP |
| Generic Name | HEMOSTATIC METAL CLIP FOR THE GI TRACT |
| Product Code | HBT |
| Date Received | 2019-02-06 |
| Model Number | M00521230 |
| Catalog Number | 08714729875628 |
| Lot Number | 2265523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |