MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-26 for CHATTANOOGA 2841 manufactured by Djo, Llc.
[4384199]
An mdr reportable event. Complaint rec'd from clinician that alleges "pt was receiving tractione treatment - pt rang call bell. Unit had not stopped pulling abd pts head was out of traction. " questionnaire not rec'd from clinician and/or pt. No injury reported, therefore no medical treatment at time of incident or after reported. Product not returned to mfr for review. No indication event caused or contributed to permanent impairment, serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00008 |
| MDR Report Key | 3810909 |
| Report Source | 05 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-25 |
| Date of Event | 2014-03-13 |
| Date Added to Maude | 2014-06-02 |
| 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 | CHATTANOOGA |
| Generic Name | TRITON DTS |
| Product Code | ITH |
| Date Received | 2014-03-26 |
| Catalog 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-26 |