FDA Adverse Event
Injury
Summary report: N
ICY HOT PRO-THERAPY INSTANT COLD PACKS
MDR report key: 2160783
·
Received July 7, 2011
Report
- Report Number
- 1022556-2011-00016
- Event Type
- Injury
- Date Received
- July 7, 2011
- Report Date
- July 7, 2011
- Product Code
- IMD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS DISCONTINUED IN (B)(4) 2008.
Description of Event or Problem · 1
(B)(6) , 2011 RECEIVED COMMUNICATION FROM CONSUMER STATING INJURY RECEIVED FROM USE OF PRODUCT, NO DETAIL PROVIDED EITHER FOR SPECIFIC PRODUCT OR INJURY. THE CONSUMER WAS SENT COMMUNICATION REQUESTING INFORMATION AS TO THE NATURE OF HER INJURY. (B)(6), 2011 RECEIVED COMMUNICATION FROM CONSUMER STATING UPON USE OF THE INSTANT COLD PACKS, APPLIED FOR 10 TO 15 MINS TO EACH LOWER LEG SIMULTANEOUSLY. THE CONSUMER STATES SHE THEN EXPERIENCED A RASH WITH SWELLING AND BLISTERING WHICH HAS HEALED WITH HYPOPIGMENTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICY HOT PRO-THERAPY INSTANT COLD PACKS | NONE | IMD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Disability |