MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-19 for INTELECT MOBILE COMBO 2778 2738 manufactured by Djo Global.
[17410677]
Mobile stim had intensity shoot up suddenly and caused muscle spasm and pain to pt. Questionnaire indicated that it was a (b)(6) male weighing (b)(6) with a pre-existing condition of a hamstring grade 1 tear. The questionnaire reported that the pt did not have allergies to latex and there were no abnormalities present on the skin. Treatment was not interrupted but questionnaire indicated that progress towards recovery was impeded due to the incident as the muscle spasm. The wave treatment used was ifc 2 pole and no error was displayed on the unit but intensity increase was displayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00104 |
| MDR Report Key | 2259132 |
| Report Source | 99 |
| Date Received | 2011-09-19 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-08-22 |
| Date Added to Maude | 2011-09-23 |
| 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 STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| 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 | INTELECT MOBILE COMBO |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMI |
| Date Received | 2011-09-19 |
| Model Number | 2778 |
| Catalog Number | 2738 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-09-19 |