MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-29 for CHATTANOOGA TX TRACTION UNIT PKG 4759 manufactured by Djo, Llc.
[145630069]
The customer did not indicate that the device will be returned for evaluation. If the device becomes available as such, a follow-up report will be completed upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145630070]
It was reported that "it is having an intermittent issue... When the unit has been sitting idle with the rope out and they go to remove all of the slack once attached to the patient, they press the rope release and it violently snaps back with force and a loud noise. Then the rope release will operate normally again in and out until it has been sitting idle again for some time. " there was no reported patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00020 |
| MDR Report Key | 8562142 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-29 |
| 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 75067 |
| Manufacturer Country | US |
| Manufacturer Postal | 75067 |
| 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 | CHATTANOOGA TX TRACTION UNIT PKG |
| Generic Name | EQUIPMENT, TRACTION, POWERED |
| Product Code | ITH |
| Date Received | 2019-04-29 |
| Model Number | 4759 |
| 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 | 2019-04-29 |