MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-26 for COMFORT COOL THUMB CMC RESTRICTION SPLINT. NC79564 manufactured by Scott Specialities Inc.
[2387019]
The customer had an allergic reaction and broke out into a rash after wearing the thumb cmc restriction splint. The splint is a latex free product.
Patient Sequence No: 1, Text Type: D, B5
[9295225]
Na.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2011-00006 |
| MDR Report Key | 2249584 |
| Report Source | 04 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-23 |
| Date of Event | 2010-08-19 |
| Date Mfgr Received | 2010-08-19 |
| Date Added to Maude | 2012-06-28 |
| 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 SPECIALITIES 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 | 2011-08-26 |
| Model Number | NA |
| Catalog Number | NC79564 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCOTT SPECIALITIES INC |
| Manufacturer Address | BELLEVILLE KS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |