ADJUSTAFIT BOOT AL256003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for ADJUSTAFIT BOOT AL256003 manufactured by Breg, Inc..

Event Text Entries

[112287752] Product has been returned for evaluation. 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


[112287753] 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 Number2028253-2018-00005
MDR Report Key7605870
Date Received2018-06-15
Date of Report2018-06-12
Date Mfgr Received2018-05-18
Date Added to Maude2018-06-15
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 NameADJUSTAFIT BOOT
Generic NameADJUSTAFIT BOOT
Product CodeIQI
Date Received2018-06-15
Returned To Mfg2018-06-05
Model NumberAL256003
Catalog NumberAL256003
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBREG, INC.
Manufacturer Address2885 LOKER AVE EAST CARLSBAD CA 92010 US 92010


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-15

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