MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-13 for DONJOY FULLFORCE,ACL,STD,CALF,RT,S 11-0258-2 manufactured by Djo, Llc.
[174735482]
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
[174735483]
It was reported that the patient "was wearing his brace on right knee due to previous acl (anterior cruciate ligament) surgery, during basketball practice. He was running down the court and went to turn when he felt a "pop" in his right knee followed by minor pain. We called his surgeon the following day and he was seen in his office 1 week later. Had mri (magnetic resonance imagery) done on (b)(6) 2019 which showed a complete tear of right acl graft. Saw surgeon on (b)(6) 2019 and had repeat surgery on (b)(6) 2019. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2020-00003 |
| MDR Report Key | 9580987 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-13 |
| 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,STD,CALF,RT,S |
| Generic Name | JOINT, KNEE, EXTERNAL BRACE |
| Product Code | ITQ |
| Date Received | 2020-01-13 |
| Model Number | 11-0258-2 |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |