PKR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for PKR manufactured by .

Event Text Entries

[65310344] The amount of floaters in the eye has increased after getting pkr on eyes. I wasn't a candidate for lasik because my lining was too thin. Lasik vision institute.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067305
MDR Report Key6260937
Date Received2017-01-17
Date of Report2017-01-17
Date of Event2015-05-13
Date Added to Maude2017-01-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePKR
Generic NamePKR
Product CodeHLQ
Date Received2017-01-17
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-01-17

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