MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-09 for CHATTANOOGA 2783 manufactured by Djo, Llc.
[74739507]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[74739508]
Complaint received that alleges "shocked the patient, she grabbed the electrode and says that it felt like a cattle prod shocked her. She had an intense headache, shaking and tingling in her left hand". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation. No indication event caused or contributed to serious injury, permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2017-00008 |
| MDR Report Key | 6554312 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-04 |
| Date Added to Maude | 2017-05-09 |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| 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 | CHATTANOOGA |
| Generic Name | INTELECT TRANSPORT 2CH STIM US STD |
| Product Code | IMI |
| Date Received | 2017-05-09 |
| Returned To Mfg | 2017-06-02 |
| Model Number | 2783 |
| Device Availability | R |
| 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. Other | 2017-05-09 |