FDA Adverse Event
Summary report: N
SUPER XL ENEMA KIT
MDR report key: 16473
·
Received March 3, 1994
Report
- Report Number
- MW4000483
- Date Received
- March 3, 1994
- Report Date
- March 3, 1994
- Manufacturer
- E-Z-EM, INC.
- Product Code
- FGD
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING PROCEDURE, PT EXPERIENCED PALPITATIONS, SWEATING, DIZZINESS AND NAUSEA. PT WAS TRANSFERRED TO EMERGENCY ROOM AND HAD BP OF 60/40 (HYPOTENSION). PT WAS RELEASED 3/3/94.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER XL ENEMA KIT | FGD | E-Z-EM, INC. | 09902620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |