UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for UNK manufactured by Unk.

Event Text Entries

[87885129] I treated a patient today that had a serious eye infection and bought her contact lenses illegally from (b)(6) without a prescription. The ocular surface was severely damaged to over wear and over use. This is precisely why we renew cl rx's on an annual basis so this sort of thing does not happen. All cl patients need an updated rx before online vendors shipping lenses to patients. This is to protect patients from potential severe eye conditions such as the ones i treated today.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072540
MDR Report Key6903654
Date Received2017-09-29
Date of Report2017-09-27
Date of Event2017-09-27
Date Added to Maude2017-09-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationOTHER CAREGIVERS
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNK
Generic NameCONTACT LENSES
Product CodeHQD
Date Received2017-09-29
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2017-09-29

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