FDA Adverse Event
Other
Summary report: N
COMFORT COOL THUMB CMC RESTRICTION SPLINT.
MDR report key: 2249584
·
Received August 26, 2011
Report
- Report Number
- 2939821-2011-00006
- Event Type
- Other
- Date Received
- August 26, 2011
- Date of Event
- August 19, 2010
- Report Date
- August 23, 2011
- Manufacturer
- SCOTT SPECIALITIES INC
- Product Code
- ILH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
THE CUSTOMER HAD AN ALLERGIC REACTION AND BROKE OUT INTO A RASH AFTER WEARING THE THUMB CMC RESTRICTION SPLINT. THE SPLINT IS A LATEX FREE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMFORT COOL THUMB CMC RESTRICTION SPLINT. | THUMB CMC RESTRICTION SPLINT. | ILH | SCOTT SPECIALITIES INC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |