MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-06 for INTELECT XT 2CH COMBO PKG 2760 manufactured by Dj Orthopedics De Mexico, S.a. De C.v..
[15535803]
Reported complaint is for shock to pt, with no indication of burn. Initial assessment indicated event not reportable, however follow-up info received after 30-day reporting time period indicated reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00097 |
| MDR Report Key | 2245854 |
| Report Source | 05 |
| Date Received | 2011-09-06 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-06-22 |
| Date Added to Maude | 2011-09-14 |
| 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 |
| 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 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 XT 2CH COMBO PKG |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMG |
| Date Received | 2011-09-06 |
| Model Number | 2760 |
| ID Number | APPLICATOR: 27384 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Address | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO TIJUANA 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-06 |