FDA Adverse Event
Summary report: N
HIR-202
MDR report key: 437729
·
Received January 10, 2003
Report
- Report Number
- 1221261-2003-00004
- Date Received
- January 10, 2003
- Report Date
- January 7, 2003
- Manufacturer
- LEVEL 1, INC.
- Product Code
- KZD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SALES REP. STATED THAT THEY HOOKED UP THE HIR-2002 TO THE PRESSURE SOURCE, THEN TURNED THE REGULATOR KNOB ON FULLY AND THE BLADDER KEPT INFLATING UNTIL IT RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIR-202 | PRESSURE INFUSER | KZD | LEVEL 1, INC. | HIR-2002 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |