MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-05 for TRITON DTS PKG US STD 2841 manufactured by Djo, Llc.
[137848837]
There is no indication that the device will be returned to the manufacturer for evaluation. If the device is returned, the device will be evaluated and a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[137848838]
It was reported that the traction device was experiencing inconsistent rope recoil. The rope starts making a clicking sound and stops working. There is no indication that there was any patient involvement or patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00010 |
| MDR Report Key | 8389946 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-05 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2018-10-23 |
| Date Added to Maude | 2019-03-05 |
| 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 | MR. BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE TX 750679663 |
| Manufacturer Country | US |
| Manufacturer Postal | 750679663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, B.C. 22244, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITON DTS PKG US STD |
| Generic Name | EQUIPMENT, TRACTION, POWERED |
| Product Code | ITH |
| Date Received | 2019-03-05 |
| Model Number | 2841 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-05 |