MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-01 for MAX TRAX WALKER 79-95495 manufactured by Djo, Llc.
[4227325]
Per 21 cfr 803, an mdr reportable event, complaint received from patient that alleges "patient noticed, a small red area on my left lateral portion of my foot less than the size of a dime. But tuesday, it was the size of a quarter and i began to be concerned. I wore another boot from my prior condition and saw my doctor. At that time, the red area was the size of a 50 cent piece and heading towards my toes. She made the diagnosis cellulitis. It spread rapidly through out my entire lateral and upper foot and toes. " questionnaire not received from clinician and/or patient. Product no returned to manufacturer for review. No indication device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2014-00009 |
| MDR Report Key | 3735657 |
| Report Source | 04 |
| Date Received | 2014-04-01 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-04-10 |
| 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. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAX TRAX WALKER |
| Generic Name | WALKER BOOT |
| Product Code | IPG |
| Date Received | 2014-04-01 |
| Model Number | 79-95495 |
| 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. Other | 2014-04-01 |