PLAZLYTE STERILIZER ABT 1.0 PL006-01-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-02-13 for PLAZLYTE STERILIZER ABT 1.0 PL006-01-02 manufactured by Abtox Inc.

Event Text Entries

[92609] Pt developed postop cornea endothelial cell decompensation. Surgical instruments were sterilized in the plazlyte process. Cause is unk. Similar surgeries were performed with instruments sterilized in the same process without adverse event. Published literature lists causes of corneal decompensation to include surgical techniques, residual detergent/gluteraldehyde, etc.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939576-1998-00006
MDR Report Key148928
Report Source06
Date Received1998-02-13
Date Facility Aware1998-01-14
Report Date1998-01-30
Date Mfgr Received1998-01-30
Date Added to Maude1998-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLAZLYTE STERILIZER
Generic NameGAS STERILIZER
Product CodeFLF
Date Received1998-02-13
Model NumberABT 1.0
Catalog NumberPL006-01-02
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age3 MO
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key145135
ManufacturerABTOX INC
Manufacturer Address104 TERRACE DR MUNDELEIN IL 60060 US
Baseline Brand NamePLAZLYTE STERILIZER
Baseline Generic NameGAS STERILIZER
Baseline Model NoABT 1.0
Baseline Catalog NoPL006-01-02
Baseline ID*
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK905119
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 1998-02-13

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