MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-03 for DONJOY 11-1440-2 manufactured by Djo, Llc.
[66477151]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[66477152]
Complaint received that alleges "customer stated that the brace fit fine, did not notice anything until after her ski trip, took off brace and foot felt numb, ended up falling because of her foot and sprained her ankle. According to her doctor, the issue with her foot was caused by the brace". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation. No indication event caused or contributed to serious injury, permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2017-00002 |
| MDR Report Key | 6300394 |
| Report Source | CONSUMER |
| Date Received | 2017-02-03 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-02-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 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 |
| Generic Name | ARMOR FP,ACL,RT,S |
| Product Code | ITM |
| Date Received | 2017-02-03 |
| Model Number | 11-1440-2 |
| 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 STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-03 |