MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-08-25 for SOLUTIONS 4CH COMBO PKG 2864 manufactured by Djo Global.
[2380547]
Patient burned on quad. Approximately 1" diameter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00096 |
| MDR Report Key | 2236493 |
| Report Source | 99 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-07-29 |
| Date Added to Maude | 2011-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLUTIONS 4CH COMBO PKG |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMG |
| Date Received | 2011-08-25 |
| Catalog Number | 2864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-25 |