FDA Adverse Event
Other
Summary report: N
ICY HOT HEAT THERAPY PATCH
MDR report key: 1353547
·
Received March 20, 2009
Report
- Report Number
- 1022556-2009-00016
- Event Type
- Other
- Date Received
- March 20, 2009
- Report Date
- February 26, 2009
- Manufacturer
- CHATTEM, INC.
- Product Code
- IMD
- Removal / Correction Number
- Z-1197-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVALUATION AND ANALYSIS. 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. INSTEAD, OUR INVESTIGATION HAS DETERMINED THAT THE PATIENT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE 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 SKIN BEING PULLED OFF UPON REMOVAL OF PATCH FROM BICEP AREA. PRODUCT WAS WORN FOR APPROXIMATELY 7 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICY HOT HEAT THERAPY PATCH | IMD | CHATTEM, INC. | 083 | 2A7PR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |