MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-27 for SENIOR SOLUTIONS 2CH COMBO PKG 2863 manufactured by Djo Llc.
[2418455]
(b)(6) 2011. Unit alleged to have caused second degree burns including blistering under the electrodes. Medical treatment at the time of the incident was not reported. Further medical treatment was not reported.
Patient Sequence No: 1, Text Type: D, B5
[9590126]
The device was evaluated by djo. The unit was found to be operating within specifications. However, channel 2 stim wire was found to have open/intermittent impedance. The electrode had poor adhesion and a high impedance. From djo's evaluation, the open/intermittent lead and high impedance electrodes may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2012-00007 |
| MDR Report Key | 2434560 |
| Report Source | 06 |
| Date Received | 2012-01-27 |
| Date of Report | 2012-01-27 |
| Date of Event | 2011-12-30 |
| Date Mfgr Received | 2011-12-30 |
| Date Added to Maude | 2012-02-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENIOR SOLUTIONS 2CH COMBO PKG |
| Generic Name | SENIOR SOLUTIONS |
| Product Code | IMJ |
| Date Received | 2012-01-27 |
| Returned To Mfg | 2011-12-30 |
| Model Number | 2863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-27 |