FDA Adverse Event
Other
Summary report: N
THUMB CMC ABDUCTION SPLINT
MDR report key: 2249646
·
Received August 26, 2011
Report
- Report Number
- 2939821-2011-00003
- Event Type
- Other
- Date Received
- August 26, 2011
- Date of Event
- May 17, 2011
- Report Date
- August 22, 2011
- Manufacturer
- SCOTT SPECIALITIES, INC.
- Product Code
- ILH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
THE THERAPIST WAS INSTRUCTING HER (B)(6) PT ON HANDLING AND USE OF THE COMFORT COOL ABDUCTION SPLINT WHILE HEATING IT IN THE MICROWAVE TO SOFTEN THE THERMOPLASTIC PLASTIC SUPPORT FOR A CUSTOM FIT ON HER PT'S WRIST. THE INSTRUCTIONS FOR USE INDICATE "TO HEAT THE SPLINT AT 20 SECOND INTERVALS" AND FOR A TIME "NO LONGER THAN 2 MINUTES." THE SPLINT WAS OVERHEATED AND CAUGHT FIRE IN THE MICROWAVE, RENDERING THE PRODUCT UNUSABLE FOR THE PT. THERAPIST DID NOT FOLLOW PRODUCT INSTRUCTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THUMB CMC ABDUCTION SPLINT | THUMB CMC ABDUCTION SPLINT | ILH | SCOTT SPECIALITIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |