MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-30 for TRITON DTS PKG US STD 2841 manufactured by Djo, Llc.
[134460331]
The device is expected to be returned for evaluation. A follow-up report will be submitted upon completion thereof.
Patient Sequence No: 1, Text Type: N, H10
[134460332]
It was reported that the traction device powered off and turned on again during treatment. It then suddenly pulled on the patient's neck. There was reportedly no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00005 |
| MDR Report Key | 8288448 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2019-01-30 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| 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 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 DTS PKG US STD |
| Generic Name | EQUIPMENT, TRACTION, POWERED |
| Product Code | ITH |
| Date Received | 2019-01-30 |
| Model Number | 2841 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-01-30 |