MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-18 for TRITON 4739 manufactured by Djo, Llc.
[4685568]
Complaint received from clinician that alleges "the unit keeps pulling after treatment". Questionnaire received from clinician stating no injury, patient felt unit continued pulling and pushed button to stop. No injury, therefore no medical treatment at time of incident or after. Product not returned to manufacturer for review. No indication event caused or contributed to permanent impairment, injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00007 |
| MDR Report Key | 3847675 |
| Report Source | 04 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-02-20 |
| Date Added to Maude | 2014-06-19 |
| 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 | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A., 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 | TRITON |
| Generic Name | TRITON TRACTION DOM PKG |
| Product Code | ITH |
| Date Received | 2014-03-18 |
| Model Number | 4739 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-18 |