MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-09 for CHATTANOOGA INTC B manufactured by Djo, Llc.
[30830795]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[30830796]
Complaint received that alleges "the unit has burned a patient". Product not returned for evaluation. Product questionnaire received from clinician and/or patient. Event did interrupt treatment, recovery was impeded. Patient received third degree burn under 1 electrode, superficial burn under one electrode. Patient received treatment at the time of the incident, and was referred for follow up with doctor post event.
Patient Sequence No: 1, Text Type: D, B5
[48556645]
Product was returned for review. The product malfunctioned or failed to meet specifications. The malfunction or failure is not related to the event. No problems were duplicated that may have caused or contributed to the event. All treatments were run for full duration and no problems were duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2015-00028 |
| MDR Report Key | 5212279 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-09 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-10-06 |
| Date Added to Maude | 2015-11-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MEXICO 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | INTELECT COMBO PACKAGE |
| Product Code | IPF |
| Date Received | 2015-11-09 |
| Model Number | INTC B |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-09 |