MAXTRAX WALKER (BOOT) (DJO, LLC) (REF NO) 11-1382-4-00000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-19 for MAXTRAX WALKER (BOOT) (DJO, LLC) (REF NO) 11-1382-4-00000 manufactured by Djo, Llc.

Event Text Entries

[16831050] Had injury to foot, ankle & leg (right) in 2007. Taken to emergency. Diagnosis-fractures, "crushed foot", sprained ankle, plus 2 lesions and a fracture blister) had large hardened hematoma (approx 3"x3") dark red, swollen-left side near ankle. Stitches were put on other wound on right side. Followed instructions for cleaning/changing dressings on 3 lesions for 5 days until dr appt (dr), six days later. Left side (of right foot) wound was healing - softened blister formed on left top edge - just before dr appt (have photos) after nurse in dr office changed bandages on wound (while was on pain medication), man came in talking quickly, with this "fracture foot" pushed me to put boot on even after, i said it was too painful to fit my swollen foot/ankle in it. Dr was not around. I was in wheelchair, in shock, i tried to bear it, but after i got home, it became excruciating pain & i found boot burst "hematoma" prematurely-ripped skin off-causing open wound, reddened skin. Elsewhere, further injury pain and fear of dr and infection. Wound has not healed after one month. (stitched wound is still red on other side) i took "boot" off after a few hours, on the same day, when pain was unbearable. When bandage was removed the next day. I saw damages from boot). [we have photos from various stages before. After boot damage and removal]. Dates of use: 2007. Diagnosis or reason for use: fractures/contusions/soft tissue damage of lesions, sprained ankle, hematoma internal injuries. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5004489
MDR Report Key951200
Date Received2007-11-19
Date of Report2007-11-04
Date of Event2007-09-19
Date Added to Maude2007-12-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMAXTRAX WALKER (BOOT) (DJO, LLC)
Generic Name"FRACTURE BOOT" " WALKER BOOT"
Product CodeIPG
Date Received2007-11-19
Model Number(REF NO) 11-1382-4-00000
Lot Number090507
ID NumberH80511138240000016
OperatorOTHER
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key925045
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST VISTA CA 92081 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2007-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.