MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-04-03 for ULTRASOUND APPLICATOR 2 CM SQ 78048 manufactured by Djo, Llc.
[2618172]
Pt reported brief electric poke with initial ultrasound treatment. More ultrasound treatment. More ultrasound gel was applied but the pt still felt the electric poke. Ultrasound head was changed and pt reported no electric sensations. Device was not returned to mfr. No add'l info was received regarding the complaint. The customer was contacted to gather add'l info with no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2012-00020 |
| MDR Report Key | 2535158 |
| Report Source | 00 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-04-03 |
| Date of Event | 2011-12-22 |
| Date Mfgr Received | 2012-03-06 |
| Date Added to Maude | 2012-09-07 |
| 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 | 0 |
| 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 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA B.C. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND APPLICATOR 2 CM SQ |
| Generic Name | ELECTROTHERAPY - ELECTRODES |
| Product Code | IMI |
| Date Received | 2012-04-03 |
| Model Number | 78048 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-03 |