MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for EXOS SPLINT manufactured by Djo, Llc.
[135921529]
The pt was placed in a splint in the orthopedic office. She went to the ed complaining that the splint was causing pain and a reddened area. The ed placed a new splint. It was discovered that the foam inside of the splint had been cut too short, exposing the hard area of the splint on a portion of the splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083846 |
| MDR Report Key | 8320671 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-12-26 |
| Date Added to Maude | 2019-02-08 |
| 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 |
| 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 | EXOS SPLINT |
| Generic Name | SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE |
| Product Code | NOC |
| Date Received | 2019-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-07 |