MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-01-11 for PROCARE manufactured by Djo Llc..
[15196406]
Received notification from a law firm claiming that their client fell "[as] a result of the post operative boot manufactured by pro-care [? ] and as a result of this fall, she sustained substantial and permanent injuries for which she will require surgical intervention. " no add'l info was provided. Specific info of the involved device and the nature of the claimed injuries is not known at this time. The product was not returned for eval or investigation.
Patient Sequence No: 1, Text Type: D, B5
[15720904]
No add'l info was provided. Specific info of the involved device and the nature of the claimed injuries is not known at this time. The product was not returned for eval or investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2012-00003 |
| MDR Report Key | 2419393 |
| Report Source | 00 |
| Date Received | 2012-01-11 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-12 |
| Date Mfgr Received | 2011-12-12 |
| Date Added to Maude | 2012-01-19 |
| 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 | 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 | 7607271280 |
| 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. |
| Manufacturer Country | MX |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCARE |
| Generic Name | PROCARE POST OP BOOT |
| Product Code | IPG |
| Date Received | 2012-01-11 |
| Operator | LAY USER/PATIENT |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-11 |