MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for THUMB CMC ABDUCTION ORTOHSIS NC79499-P manufactured by North Coast Medical, Inc..
[125330887]
Adverse reaction to thumb cmc abduction orthosis prescribed for thumb/wrist sprain (was originally as broken) made from neoprene with anti-microbial treated terrycloth lining. I developed a burn-like reaction on wrist that itched, blistered, peeled and also developed a rash. The burn/peeling was under the splint on the wrist and the rash began at the bottom of my thumb and extended across the back of my hand. Almost four weeks later (removing it after two weeks), i still have the rash. Made in (b)(6), mfg by north coast medical, inc. Thank you.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080820 |
| MDR Report Key | 8008919 |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-10-05 |
| Date Added to Maude | 2018-10-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THUMB CMC ABDUCTION ORTOHSIS |
| Generic Name | SPLINT, HAND, AND COMPONENTS |
| Product Code | ILH |
| Date Received | 2018-10-25 |
| Model Number | NC79499-P |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-25 |