MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-26 for THUMB CMC ABDUCTION SPLINT NC79494 manufactured by Scott Specialities, Inc..
[15197755]
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.
Patient Sequence No: 1, Text Type: D, B5
[15795812]
Na.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00003 |
| MDR Report Key | 2249646 |
| Report Source | 05 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN LYNCH |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | SCOTT SPECIALITIES, INC. |
| Manufacturer Street | 512 M ST |
| Manufacturer City | BELLEVILLE KS 66935 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66935 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THUMB CMC ABDUCTION SPLINT |
| Generic Name | THUMB CMC ABDUCTION SPLINT |
| Product Code | ILH |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC79494 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCOTT SPECIALITIES, INC. |
| Manufacturer Address | BELLLEVILLE KS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-26 |