FDA Adverse Event
Injury
Summary report: N
UNKNOWN COLD PACK
MDR report key: 649258
·
Received December 5, 2005
Report
- Report Number
- 1423507-2005-00141
- Event Type
- Injury
- Date Received
- December 5, 2005
- Date of Event
- October 7, 2003
- Report Date
- December 5, 2005
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KYR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
ACCORDING TO INFO FORWARDED BY CARDINAL LEGAL DEPT., IN 2003, WHILE AT HER PLACE OF EMPLOYMENT PT FELT A MUSCLE PULL IN HER UPPER BACK. PT RECEIVED FROM HER WORKPLACE A JACK FROST ICE PACK WHICH SHE "WRAPPED IN A TOWEL AND PLACED ON THE INJURED AREA OF HER BACK. WITHIN TWO OR THREE MINUTES, PT FELT A BURNING SENSATION ON HER BACK WHERE SHE HAD PLACED THE ICE PACK. SHE IMMEDIATELY REMOVED THE ICE PACK. PT SUSTAINED A PARTIAL THICKNESS BURN ON HER BACK ON THE AREA WHERE SHE HAD PLACED THE ICE PACK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN COLD PACK | UNKNWON COLD PACK | KYR | CARDINAL HEALTH | UNKCOLDPK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |