FULL ATUO REF-KERATOMETER RK-F2 6937B002AA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-28 for FULL ATUO REF-KERATOMETER RK-F2 6937B002AA manufactured by Canon, Inc..

Event Text Entries

[19193898] The customer reported that they were getting inaccurate readings when using the device.
Patient Sequence No: 1, Text Type: D, B5


[19469767] Investigation is still in-progress. If additional information is received regarding the investigation, a supplemental report will be submitted per 21 cfr 803. 56. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1000181430-2012-00080
MDR Report Key2941766
Report Source06
Date Received2012-12-28
Date of Report2012-10-10
Date Mfgr Received2012-10-10
Device Manufacturer Date2012-09-01
Date Added to Maude2013-03-26
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 FDA0
Event Location0
Manufacturer ContactMR. NAOYASU ASAKA, MANAGER
Manufacturer Street30-2 SHIMOMARUKO, 3-CHOME OHTA-KU
Manufacturer CityTOKYO 146-8501
Manufacturer CountryJA
Manufacturer Postal146-8501
Manufacturer Phone37582111
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameFULL ATUO REF-KERATOMETER RK-F2
Product CodeHKO
Date Received2012-12-28
Model NumberRK-F2
Catalog Number6937B002AA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCANON, INC.
Manufacturer Address30-2 SHIMOMARUKO, 3-CHOME OHTA-KU TOKYO 146-8501 JA 146-8501


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-28

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