FDA Adverse Event
Other
Summary report: N
HEEL HUGGER
MDR report key: 551028
·
Received October 21, 2004
Report
- Report Number
- 551028
- Event Type
- Other
- Date Received
- October 21, 2004
- Date of Event
- September 23, 2004
- Report Date
- October 21, 2004
- Manufacturer
- CHILDREN'S MEDICAL VENTURES, INC.
- Product Code
- FMT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
THE PRODUCT IS A "HEEL HUGGER" A HEEL WARMER. IT WAS BEING USED AS A WARM PACK TO TREAT AN IV INFILTRATE. THE NURSE ACTIVATED THE WARMING PACK AS INSTRUCTED AND UPON REMOVAL FROM THE SITE THE NURSE NOTED SMALL YELLOW BLISTERS OVER THE WRIST AREA. WHEN THE NURSE EXAMINED THE PACK, IT WAS NOTICED THAT IT WAS LEAKING. NOTE, THERE WERE NO BLISTERS AT THE IV INFILTRATE SITE PRIOR TO USE OF THE PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEEL HUGGER | INFANT HEEL WARMER | FMT | CHILDREN'S MEDICAL VENTURES, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 DA | NO OTHER THERAPIES |