MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for RADIAL JAW 4 SINGLE USE BIOPSY FORCEP MOO513330 manufactured by Boston Scientific Corporation.
[181802251]
Biopsy forceps came out of the package with the tip bent. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093376 |
| MDR Report Key | 9769992 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-18 |
| Date Added to Maude | 2020-02-28 |
| 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 | 3 |
| Brand Name | RADIAL JAW 4 SINGLE USE BIOPSY FORCEP |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC |
| Product Code | FCL |
| Date Received | 2020-02-27 |
| Catalog Number | MOO513330 |
| Lot Number | 24902512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | EL COYOL, ALAJUELA, CR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |