DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS CF 440

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2019-08-22 for DR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS CF 440 manufactured by Bayer Healthcare Llc, Consumer Care.

MAUDE Entry Details

Report Number2248903-2019-00003
MDR Report Key8922222
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2019-08-22
Date of Report2019-08-22
Date of Event2019-01-01
Date Mfgr Received2019-08-16
Date Added to Maude2019-08-22
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 ContactK. LAMBERSON
Manufacturer Street100 BAYER BLVD. P.O. BOX 915
Manufacturer CityWHIPPANY NJ 079810915
Manufacturer CountryUS
Manufacturer Postal079810915
Manufacturer G1BAYER HEALTHCARE LLC, CONSUMER CARE
Manufacturer Street36 COLUMBIA RD.
Manufacturer CityMORRISTOWN NJ 07960
Manufacturer CountryUS
Manufacturer Postal Code07960
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR SCHOLLS CUSTOM FIT ORTHOTIC INSERTS CF 440
Generic NameORTHOSIS, CORRECTIVE SHOE LIMB ORTHOSIS
Product CodeKNP
Date Received2019-08-22
Model NumberNA
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBAYER HEALTHCARE LLC, CONSUMER CARE
Manufacturer Address36 COLUMBIA RD. MORRISTOWN NJ 07960 US 07960


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-22

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