MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-09-06 for WALKER manufactured by Dj Orthopedics De Mexico, S.a. De C.v..
[2196215]
Pt reports a three (3) inch cut between knee and ankle that happened during the night causing bleeding. Pt sought medical intervention. Djo considers any incident that requires medical intervention be treated as a reportable event. The device has not been received for eval. No add'l info has been received or confirmed. Investigation on-going. Obtaining more info on type and size of walker boot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00098 |
| MDR Report Key | 2245857 |
| Report Source | 04 |
| Date Received | 2011-09-06 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-08-04 |
| Date Added to Maude | 2011-09-14 |
| 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 ST. |
| 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. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKER |
| Generic Name | WALKER BOOT |
| Product Code | IPG |
| Date Received | 2011-09-06 |
| 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 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Address | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO TIJUANA 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-06 |