MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-14 for DONJOY FULLFORCE,ACL,SHRT CF,RT,XS 11-3220-1 manufactured by Djo, Llc.
[179432134]
No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[179432135]
It was reported that "while she was wearing her brace, she was running a pass on one of her events, the double mini-trampoline. As she was exiting the trampoline, she was doing a full twist in the air. When she landed, her body was still in rotation when her feet planted on the mat. That was when she heard the pop of her right knee. Even with her brace on, she still managed to tear her acl (anterior cruciate ligament) graft in half. Surgery date is set for (b)(6) 2020. " no further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2020-00008 |
| MDR Report Key | 9711294 |
| Report Source | CONSUMER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2017-11-29 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| 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 |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY FULLFORCE,ACL,SHRT CF,RT,XS |
| Generic Name | JOINT, KNEE, EXTERNAL BRACE |
| Product Code | ITQ |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 11-3220-1 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |