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 COMFORT COOL THUMB CMC RESTRICTION SPLINT NC79564 manufactured by North Coast Medical, Gilroy.
[2300904]
Customer developed a rash after wearing the thumb cmc restriction splint for four days. The splint is a latex free product.
Patient Sequence No: 1, Text Type: D, B5
[9457147]
Add'l catalog# nc79565.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00011 |
| MDR Report Key | 2249645 |
| Report Source | 05 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-24 |
| Date of Event | 2009-01-09 |
| Date Mfgr Received | 2009-01-09 |
| Date Added to Maude | 2012-06-27 |
| 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 | COMFORT COOL THUMB CMC RESTRICTION SPLINT |
| Generic Name | THUMB CMC RESTRICTION SPLINT |
| Product Code | ILI |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC79564 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, GILROY |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |