FDA Adverse Event
Malfunction
Summary report: N
COMPRESS INSTANT ICE - LARGE
MDR report key: 1243843
·
Received June 24, 2008
Report
- Report Number
- 1219232-2008-00005
- Event Type
- Malfunction
- Date Received
- June 24, 2008
- Date of Event
- December 11, 2007
- Report Date
- June 23, 2008
- Manufacturer
- DURO MED INDUSTRIES
- Product Code
- IMD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO IDENTIFYING INFORMATION WAS GIVEN ON THE PT IN THE REPORTER'S SUBMISSION TO THE FDA THAT WAS FORWARDED TO THE DISTRIBUTOR. ADDITIONALLY, SAMPLES WERE NOT MADE AVAILABLE, AND REPEATED ATTEMPTS AT GATHERING FURTHER INFORMATION FROM THE REPORTER WERE UNSUCCESSFUL.
Description of Event or Problem · 1
INSTANT ICE COMPRESS WAS ACTIVATED, CONTENTS LEAKED INTO END USER'S EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPRESS INSTANT ICE - LARGE | INSTANT COLD PACK | IMD | DURO MED INDUSTRIES | 79-0010-9816 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R |