FDA Adverse Event
Other
Summary report: N
ICY HOT HEAT THERAPY PATCH
MDR report key: 1071432
·
Received July 2, 2008
Report
- Report Number
- 1022556-2008-00580
- Event Type
- Other
- Date Received
- July 2, 2008
- Date of Event
- May 20, 2008
- Report Date
- June 17, 2008
- Manufacturer
- CHATTEM, INC.
- Product Code
- IMD
- Removal / Correction Number
- Z-1197-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
SINCE THIS, A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENT 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 PT 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
THE CUSTOMER CLAIMED THAT THE USE OF THE PRODUCT CAUSED BURNS WHICH REQUIRED TREATMENT FROM HER GENERAL PRACTITIONER. NO FURTHER DETAIL WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICY HOT HEAT THERAPY PATCH | IMD | CHATTEM, INC. | 083 | 2A6ZJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |