MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for COMFORT COOL THUMB CMC RESTRICTION SPLINT NC79564 manufactured by North Ccoast Medical, Inc..
[90388440]
North coast medical became aware of this issue on (b)(4) 2017 from a report by: (b)(6) of (b)(6). This was after (b)(4) of (b)(4) sent (b)(4) an incident report investigation scheme, file reference: (b)(4). After learning of this incident north coast medical, inc. Performed a material test on a sample hand splint (patient did not return the original unit), and the tests conclusion was "pass".
Patient Sequence No: 1, Text Type: N, H10
[90388441]
Patient experienced an allergic reaction to velcro.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000124207-2017-00003 |
| MDR Report Key | 6982101 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-10-26 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RUSSELL MACDERMOTT |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | NORHT COAST MEDICAL, INC. |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMFORT COOL THUMB CMC RESTRICTION SPLINT |
| Generic Name | COMFORT COOL |
| Product Code | ILH |
| Date Received | 2017-10-26 |
| Model Number | NC79564 |
| Catalog Number | NC79564 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH CCOAST MEDICAL, INC. |
| Manufacturer Address | 8100 CAMINO ARROYO GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-26 |