MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-20 for AUTOMATIC DISPENSER FOR BARIUM UNKNOWN manufactured by E-z-em.
[19161566]
During barium enema on male pt, the automatic dispenser for barium caught on fire and immediately disconnected. No pt harm. Procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW4000030 |
MDR Report Key | 10493 |
Date Received | 1993-08-20 |
Date of Event | 1993-08-20 |
Date Added to Maude | 1993-12-15 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AUTOMATIC DISPENSER FOR BARIUM |
Product Code | FCD |
Date Received | 1993-08-20 |
Model Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 10493 |
Manufacturer | E-Z-EM |
Manufacturer Address | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1993-08-20 |