*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-06 for * manufactured by Midwest Eye Laboratories.

Event Text Entries

[316830] Caller wears protective lens which they describe as a thin shell over an existing eye injury. While waiting in the office to have this lens painted, they started sneezing from strong paint smell. After wearing lens for 2 days, still was sneezing and now coughing, had lower back pain and bloody stools. Went to chiropractor who said their back pain may be due to kidney problems. Caller is currently not using lens to see if symptoms go away.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1027733
MDR Report Key446540
Date Received2003-03-06
Date of Report2003-03-06
Date of Event2003-02-20
Date Added to Maude2003-03-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NamePROTECTIVE LENS
Product CodeHQT
Date Received2003-03-06
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device Availability*
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key435510
ManufacturerMIDWEST EYE LABORATORIES
Manufacturer Address1101 WEST CLAIREMONT AVE SUITE 1-D EAU CLAIRE WI 54701 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-03-06

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