MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for MUELLER HAND BRACES manufactured by Mueller Sports Medicine Inc..
[96607564]
The braces that i wear to bed in order to strengthen my arms and hands have been problematic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074430 |
| MDR Report Key | 7168794 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-26 |
| Date Added to Maude | 2018-01-05 |
| 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 | MUELLER HAND BRACES |
| Generic Name | MUELLER HAND BRACES |
| Product Code | ILH |
| Date Received | 2018-01-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUELLER SPORTS MEDICINE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |