FDA Adverse Event
Injury
Summary report: N
ACE HEAT THERAPY PATCH
MDR report key: 1030008
·
Received April 9, 2008
Report
- Report Number
- 2243072-2008-00018
- Event Type
- Injury
- Date Received
- April 9, 2008
- Date of Event
- March 24, 2008
- Report Date
- April 7, 2008
- Manufacturer
- BECTON DICKINSON
- Product Code
- IMD
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
CONSUMER REPORTS WEARING HEAT PATCH ON RIGHT CHEST/RIB AREA FOR ABOUT TEN (10) HOURS OVERNIGHT THEN STARTED TO FEEL BURNING SENSATION. WHEN PATCH WAS REMOVED THE AREA HAD BLISTERS AND SOME SKIN WAS REMOVED. WENT TO DOCTOR WHO GAVE HER TWO (2) CREAMS TO TREAT AFFECTED AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACE HEAT THERAPY PATCH | HEAT THERAPY PATCH | IMD | BECTON DICKINSON | NA | RF12Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |