MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-21 for ARMOR FP,ACL,RT,S 11-1440-2 manufactured by Djo, Llc.
[136732422]
Initial reporter occupation: unknown. There is no indication from the customer that the device will be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[136732423]
It was reported that "there was 51 seconds left of the game, [name redacted] was bringing the ball up the court and the opposing team tried to steal the ball. The ball got loose and (b)(6) dove after it. During the dive after the ball her right knee twisted, she rolled over and grabbed her knee. She was helped off the court and assessed by their athletic trainer. This led to the retear of her acl (anterior cruciate ligament). She was wearing her brace and has always wore her brace during practices and games as well as any athletic events that she was participating in. " no further information is available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2019-00007 |
| MDR Report Key | 8357390 |
| Report Source | CONSUMER |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-12-08 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2019-02-21 |
| 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 | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| 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, B.C. 22244, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMOR FP,ACL,RT,S |
| Generic Name | CAGE, KNEE |
| Product Code | ITM |
| Date Received | 2019-02-21 |
| Model Number | 11-1440-2 |
| Operator | LAY USER/PATIENT |
| 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 | 1. Required No Informationntervention | 2019-02-21 |