MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-06-03 for DONJOY FULLFORCE 11-0265-3 manufactured by Djo, Llc.
[4671964]
Complaint received from pt that alleges "brace is broken next to join, pt injured-needs new surgery because of it". Questionnaire received from clinician and/or pt. Questionnaire stated that "because the brace broke the knee got too much in flexion: new tibia fracture: new surgery". Product not returned to mfr for review. No additional info available for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00011 |
| MDR Report Key | 3890702 |
| Report Source | 01 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-13 |
| Date Added to Maude | 2014-06-25 |
| 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 ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY FULLFORCE |
| Generic Name | FULLFORCE |
| Product Code | ITM |
| Date Received | 2014-06-03 |
| Model Number | 11-0265-3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-03 |