MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for ARMBAND PNEUMATIC manufactured by Medex/psi Premier Specialities / Djo Global.
[57468073]
I was prescribed an armband pneumatic brace from med ex/psi premier specialities inc. , and after wearing it for a few weeks. I developed a rash and intense itching in the area on the top of the forearm where the brace was. Although i have not used it since (b)(4). I still have visible skin changes and itching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065363 |
| MDR Report Key | 6025440 |
| Date Received | 2016-10-10 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-09-13 |
| Date Added to Maude | 2016-10-13 |
| 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 | ARMBAND PNEUMATIC |
| Generic Name | ARMBAND PNEUMATIC |
| Product Code | NGX |
| Date Received | 2016-10-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEX/PSI PREMIER SPECIALITIES / DJO GLOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-10 |