MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for DUPEL DUAL CHANNEL IONTOPHORESIS SYSTEM manufactured by Djo, Llc.
[87356303]
Patient Sequence No: 1, Text Type: N, H10
[87356304]
Blister under right shoulder pad; iontophoresis with dexamethasone 4mg/ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6893907 |
| MDR Report Key | 6893907 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-05-19 |
| Report Date | 2017-08-18 |
| Date Reported to FDA | 2017-08-18 |
| Date Reported to Mfgr | 2017-08-18 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | DUPEL DUAL CHANNEL IONTOPHORESIS SYSTEM |
| Generic Name | DEVICE, IONTOPHORESIS, OTHER USES |
| Product Code | EGJ |
| Date Received | 2017-09-26 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-26 |