MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-11-09 for COMFORT COOL THUMB CMC RESTRICTION SPLINT NC79560 manufactured by North Coast Medical, Inc..
[20220716]
Customer wore this splint two times. Each time he wore the splint he broke into a rash on the top of his hand and at the top part of his thumb. He could not remember the exact date he wore the splint but once he discontinued the use, the rash would disappear in two days. The splint is a latex free product.
Patient Sequence No: 1, Text Type: D, B5
[20591077]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00015 |
| MDR Report Key | 2331776 |
| Report Source | 04 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-08-22 |
| Date of Event | 2011-07-15 |
| Date Mfgr Received | 2011-07-15 |
| Date Added to Maude | 2012-07-17 |
| 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 |
| 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 SPECIALTIES INC. |
| Manufacturer Street | 512 M STREET |
| Manufacturer City | BELLEVILLE KS 66935 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66935 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT COOL THUMB CMC RESTRICTION SPLINT |
| Generic Name | THUMB CMC RESTRICTION SPLINT |
| Product Code | ILH |
| Date Received | 2011-11-09 |
| Model Number | NA |
| Catalog Number | NC79560 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | GILROY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-11-09 |