MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-12-03 for CHATTANOOGA 4759 manufactured by Djo, Llc.
[5209291]
Complaint received from customer that alleges "when the machine is started there is traction force of 2 - 3 lbs without even setting any parameters and if they put more than 40 lbs then it keeps on pulling and does not stop". Questionaire not received from clinician and/or pt. Device not returned to mfr for eval. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00019 |
| MDR Report Key | 4317189 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-12-03 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-11-20 |
| Date Mfgr Received | 2015-06-01 |
| Date Added to Maude | 2014-12-15 |
| 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 | TX TRACTION UNIT |
| Product Code | ITH |
| Date Received | 2014-12-03 |
| Model Number | 4759 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-12-03 |