JWALKER BOOT BL210005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for JWALKER BOOT BL210005 manufactured by Breg, Inc..

Event Text Entries

[98068079] Investigation of issue already completed resulting in a negligible incidence rate. Manufacturing process improvement already implemented to prevent recurrence.
Patient Sequence No: 1, Text Type: N, H10


[98068080] Reported incident of sole separating from boot. No report of injury involved with incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028253-2017-00086
MDR Report Key7206058
Date Received2018-01-19
Date of Report2018-01-15
Date Mfgr Received2017-12-27
Date Added to Maude2018-01-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. CAROL EMERSON
Manufacturer Street2885 LOKER AVENUE EAST
Manufacturer CityCARLSBAD CA 92010
Manufacturer CountryUS
Manufacturer Postal92010
Manufacturer Phone7607955823
Manufacturer G1BREG, INC.
Manufacturer Street2885 LOKER AVENUE EAST
Manufacturer CityCARLSBAD CA 92010
Manufacturer CountryUS
Manufacturer Postal Code92010
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameJWALKER BOOT
Generic NameJWALKER BOOT
Product CodeIQI
Date Received2018-01-19
Returned To Mfg2018-01-05
Model NumberBL210005
Catalog NumberBL210005
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBREG, INC.
Manufacturer Address2885 LOKER AVENUE EAST CARLSBAD CA 92010 US 92010


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-19

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