MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-10 for ORALPAK 5ML AZUL HOSPITAL 990092 manufactured by Becton Dickinson Ind. Cirurgicas Ltda.
| Report Number | 3003916417-2020-00033 |
| MDR Report Key | 9688450 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-05 |
| Date Mfgr Received | 2020-01-05 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2020-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON IND. CIRURGICAS LTDA |
| Manufacturer Street | 550 RUA CYRO CORREIA PEREIRA |
| Manufacturer City | CURITIBA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORALPAK 5ML AZUL HOSPITAL |
| Generic Name | ORALPAK |
| Product Code | KYX |
| Date Received | 2020-02-10 |
| Catalog Number | 990092 |
| Lot Number | 9028773 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON IND. CIRURGICAS LTDA |
| Manufacturer Address | 550 RUA CYRO CORREIA PEREIRA CURITIBA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |