MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-07-06 for DONJOY 11-7443-18 manufactured by .
[2116895]
Patient had previous acl rupture after which she purchased donjoy brace for prevention of recurrence. Patient sustained an acl rupture on same knee as previously reconstructed rupture while wearing brace. Patient states the knee hyperextended, though there was a stop in the brace to prevent it. Patient is an active floor ball player and at the time of injury, patient was participating in a floor ball game. Brace ifu states to lock both sides of brace at same stop. Patient is now waiting a second reconstruction surgery at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-2011-00003 |
| MDR Report Key | 2159320 |
| Report Source | 01,04 |
| Date Received | 2011-07-06 |
| Date of Report | 2011-07-06 |
| Date of Event | 2011-05-04 |
| Date Added to Maude | 2011-07-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 8003366569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY |
| Generic Name | DEFIANCE |
| Product Code | ITM |
| Date Received | 2011-07-06 |
| Model Number | 11-7443-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-06 |