SOFT SHIELD COLLAGEN CORNEAL SHIELD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for SOFT SHIELD COLLAGEN CORNEAL SHIELD manufactured by Oasis.

Event Text Entries

[7852] Collagen joined shield was not in sealed package when opened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4000222
MDR Report Key11550
Date Received1994-02-07
Date of Report1993-05-15
Date Added to Maude1994-02-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSOFT SHIELD COLLAGEN CORNEAL SHIELD
Product CodeHQN
Date Received1994-02-07
Lot Number3902B
Device Expiration Date1994-01-01
Device Availability*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11550
ManufacturerOASIS
Manufacturer AddressGLENDOLA CA 91740 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-02-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.