PROSHIELD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-11 for PROSHIELD manufactured by Alcon Laboratories, Inc..

Event Text Entries

[28073] Product did not dissolve and had to be removed from pt's eye. A corneal abrasion was observed and treated with antibiotic ointment and resolved in 5 days. The product was used after an uncomplicated cataract procedure and was soaked in tobradex prior to application. He reports the potential for injury exists if this incident were to recur.
Patient Sequence No: 1, Text Type: D, B5


[7766089] The returned unopened products were subjected to in-vitro dissolution testing. Dissolution times were longer than previously seen for this product age. The longer dissolution time is believed to be related to mfg process changes early in 1996. As a result of these complaints we have changed back to the previous process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1610287-1996-00007
MDR Report Key42782
Report Source05,06
Date Received1996-10-11
Date of Report1996-08-16
Date of Event1996-08-15
Date Mfgr Received1996-09-11
Device Manufacturer Date1996-01-01
Date Added to Maude1996-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePROSHIELD
Generic NameCORNEAL SHIELD
Product CodeMOE
Date Received1996-10-11
Model NumberNA
Catalog NumberNA
Lot Number6201620
ID NumberK902558
Device Expiration Date1998-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age7 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key43762
ManufacturerALCON LABORATORIES, INC.
Manufacturer Address6201 SOUTH FREEWAY FORT WORTH TX 761342099 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1996-10-11

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