MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-03-15 for CHATTANOOGA 2778 manufactured by Dr Comfort, A Djo, Llc Company.
[40363067]
Not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[40363068]
Complaint received that alleges "once technician believed the therapy session was completed she attempted to remove the electrodes from the patient. As she was removing the electrodes she sustained an electrical shock that gripped her hands, wrists and elbows sustained it in a flexed position. She was unable to release the electrodes until the machine was shut off by others in the room". Device not yet returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00008 |
| MDR Report Key | 5501616 |
| Report Source | FOREIGN |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2015-11-10 |
| Date Mfgr Received | 2016-02-22 |
| Date Added to Maude | 2016-03-15 |
| 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 MOBILE COMBO, INT'L STD, 5CM APPL |
| Product Code | IPF |
| Date Received | 2016-03-15 |
| Model Number | 2778 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR COMFORT, A DJO, LLC COMPANY |
| Manufacturer Address | 10300 ENTERPRISE DRIVE MEQUON 53092 US 53092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-15 |