FDA Adverse Event
Other
Summary report: N
ICY HOT PRO-THERAPY BACK BRACE
MDR report key: 1532763
·
Received November 16, 2009
Report
- Report Number
- 1022556-2009-00172
- Event Type
- Other
- Date Received
- November 16, 2009
- Report Date
- March 20, 2007
- Manufacturer
- CHATTEM, INC.
- Product Code
- IQE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.
Description of Event or Problem · 1
CONSUMER REPORTED THAT HE DEVELOPED A RASH ON STOMACH FROM USE OF PRODUCT. (B) (4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICY HOT PRO-THERAPY BACK BRACE | IQE | CHATTEM, INC. | 1811A | 06A404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |