MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-11-06 for CHATTANOOGA 1600 manufactured by Dj Orthopedics De Mexico, S.a. De C.v..
[4073609]
Complaint received that alleges "unit caught on fire. The bottom of the unit had flames and smoke coming out. Fire department was not called. The customer blew the flames out and wheeled the unit outside" product not received for eval or review at this time. No add'l info received from patient, and/or clinician regarding add'l details of incident. Complaint did not indicate event caused or contributed to permanent impairment, injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00017 |
| MDR Report Key | 3561481 |
| Report Source | 08 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-10-14 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2014-02-06 |
| 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 | 140 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 | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA B.C. |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | INTELECT SHORTWAVE |
| Product Code | IMJ |
| Date Received | 2013-11-06 |
| Model Number | 1600 |
| Catalog Number | 1600 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-06 |