FDA Adverse Event
Injury
Summary report: N
THERMOTEX
MDR report key: 1375105
·
Received May 4, 2009
Report
- Report Number
- 1528424-2009-00004
- Event Type
- Injury
- Date Received
- May 4, 2009
- Date of Event
- May 1, 2008
- Report Date
- April 13, 2009
- Manufacturer
- THERMOTEX THERAPY SYSTEMS LTD.
- Product Code
- IRT
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- ME, US
Narratives
Description of Event or Problem · 1
CS CONTACTED OUR CUSTOMER SERVICE (B)(6), 2008 AND INDICATED THAT HE DEVELOPED A BLISTER TYPE SORE ABOUT THE SIZE OF THE SILVER DOLLAR AFTER USING THE THERMOTEX HEATING PAD. MRS. (B)(6) SAW A PHYSICIAN AND HE STATED THAT IT APPEARED THAT SHE HAD SOME TYPE OF A STAFF INFECTION THAT WAS POSSIBLY DRAWN TO THE SURFACE BY THE HEAT OF THE PAD. MRS. (B)(6) WAS TAKING ANTIBIOTICS AND WAS DOING MUCH BETTER WHEN I SPOKE TO HER AGAIN IN JUNE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOTEX | INFRARED HEATING PAD | IRT | THERMOTEX THERAPY SYSTEMS LTD. | PLATINUM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |