MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for INTRAVESICAL ADMINISTRATION KIT manufactured by B. Braun Melsungen Ag.
Report Number | MW5087867 |
MDR Report Key | 8760464 |
Date Received | 2019-07-02 |
Date of Report | 2019-06-27 |
Date of Event | 2019-06-26 |
Date Added to Maude | 2019-07-03 |
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 | PHARMACIST |
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 | INTRAVESICAL ADMINISTRATION KIT |
Generic Name | PARENTERAL ADMINISTRATION KIT |
Product Code | POR |
Date Received | 2019-07-02 |
Lot Number | S190001 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | B. BRAUN MELSUNGEN AG |
Manufacturer Address | MALVERN PA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-07-02 |