MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-03 for DONJOY FULLFORCE,ACL,SHRT CF,LT,M 11-3221-3 manufactured by Djo, Llc.
[179264303]
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
[179264304]
It was reported that the patient "was working one on one with her assistant coach. She was jumping at the net and when she landed she knew it was injured. We saw her surgeon at saturday clinic the next morning where the sent her for mri (magnetic resonance imaging) and confirmed acl (anterior cruciate ligament) was torn".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2020-00007 |
| MDR Report Key | 9659548 |
| Report Source | CONSUMER |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-01 |
| Date of Event | 2019-08-30 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-03 |
| 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 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 |
| 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,LT,M |
| Generic Name | JOINT, KNEE, EXTERNAL BRACE |
| Product Code | ITQ |
| Date Received | 2020-02-03 |
| Model Number | 11-3221-3 |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-03 |