MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-23 for CE RIGHT HAND SPLINT manufactured by Corflex.
[98223637]
Reporter stated that he used a splint on his right hand for a fracture on (b)(6) 2016. A week later when the splint was removed he immediately had a rash, blister and intense itching that would have killed a less sensitive person. The orthopedist and 2 dermatologists did not know that this was a reaction to the splint and did not know how to treat it. Last week dr. (b)(6) dermatologist in (b)(6) diagnosed it as an infection similar to (b)(6) and started treatment. Reporter is concerned that product has made in (b)(6) on the box and it can be used as a weapon, therefore, the tsa and nasa should be informed. He informed the (b)(6). (b)(6) already had a similar outbreak in an (b)(6) school.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074772 |
| MDR Report Key | 7214970 |
| Date Received | 2018-01-23 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-16 |
| Date Added to Maude | 2018-01-24 |
| 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 | CE RIGHT HAND SPLINT |
| Generic Name | SPLINT |
| Product Code | IQI |
| Date Received | 2018-01-23 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORFLEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-23 |