MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-14 for TRITON DTS PKG US STD 2841 manufactured by Djo, Llc.
[133086440]
It was reported that the traction machine "will pull or release rope without any warning". The event reportedly occurred while testing the machine; there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00004 |
| MDR Report Key | 8245034 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-14 |
| Date of Report | 2019-04-10 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-01-14 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 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 | 2019-01-14 |
| Returned To Mfg | 2019-02-14 |
| Model Number | 2841 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-01-14 |