MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-30 for COMFORT COOL THUMB CMC ABDUCTION SPLINT NC79498 manufactured by North Coast Medical, Inc..
[873447]
An occupational therapist at a hospital received a thumb cmc abduction splint as a sample from north coast medical, inc to try for use approval. She contacted north coast medical, inc in 2008 to report an incident with the splint. She read the instructions for heating the splint to soften the thermoplastic insert. The instructions say to heat the splint in 20 seconds intervals, not to exceed two minutes total heating time. She said she had scanned the instructions, and the 20 second intervals did not stand out. After the splint had been heating for a continuous one minute and 30 seconds, she smelled something burning and the splint was on fire. On removing the splint from the microwave she received a burn on her finger. She reported to the emergency room at her place of employment for treatment for the burn which was reported on the emergency room report as a first degree burn. She was immediately released from the emergency room after treatment, and is not required for follow up treatments. When the therapist contacted north coast medical she told her contact she received third degree burns. This contradicts the emergency room report. Therapist acknowledged the instructions were not followed for preparing the splint.
Patient Sequence No: 1, Text Type: D, B5
[8006160]
This event occurred during the preparation of the splint prior to application. When the therapist noticed the splint was burning in the microwave, she reached in with her hand to remove it while it was still hot, which caused the first degree burn she suffered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2008-00001 |
| MDR Report Key | 1054634 |
| Report Source | 05 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-28 |
| Date of Event | 2008-05-02 |
| Date Mfgr Received | 2008-05-07 |
| Date Added to Maude | 2009-11-19 |
| 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 | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 18305 SUTTER BOULEVARD |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal | 95037 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | SCOTT SPECIALTIES, INC. |
| Manufacturer Street | 512 M STREET |
| Manufacturer City | BELLEVILLE KS 69935 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 69935 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT COOL THUMB CMC ABDUCTION SPLINT |
| Generic Name | ABDUCTION SPLINT |
| Product Code | FYH |
| Date Received | 2008-05-30 |
| Returned To Mfg | 2008-05-19 |
| Model Number | NC79498 |
| Catalog Number | NC79498 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | MORGAN HILL CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-30 |