MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for UNSPECIFIED BD URINE COLLECTION DEVICE UNKNOWN manufactured by Becton Dickinson.
Report Number | 2243072-2019-01166 |
MDR Report Key | 8693293 |
Date Received | 2019-06-12 |
Date of Report | 2019-06-11 |
Date of Event | 2019-05-23 |
Date Mfgr Received | 2019-06-03 |
Date Added to Maude | 2019-06-12 |
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 |
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 |
Manufacturer Street | 1 BECTON DRIVE |
Manufacturer City | FRANKLIN LAKES NJ 07417 |
Manufacturer Country | US |
Manufacturer Postal Code | 07417 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | UNSPECIFIED BD URINE COLLECTION DEVICE |
Generic Name | URINE COLLECTION DEVICE |
Product Code | FMH |
Date Received | 2019-06-12 |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BECTON DICKINSON |
Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-06-12 |