ABTOX ABT 1.0 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-16 for ABTOX ABT 1.0 * manufactured by Abtox, Inc..

Event Text Entries

[143745] Md reports cornea degeneration. Facility used abtox system to sterilize surgical instruments until 4/1/98.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number201951
MDR Report Key201951
Date Received1998-12-16
Date of Report1998-10-02
Date of Event1998-02-10
Report Date1998-10-02
Date Reported to Mfgr1998-10-02
Date Added to Maude1998-12-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameABTOX
Generic NamePLAZLYTE STERILIZATION SYSTEM
Product CodeFLF
Date Received1998-12-16
Model NumberABT 1.0
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityY
Device Age5 MO
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key196157
ManufacturerABTOX, INC.
Manufacturer Address104 TERRACE DRIVE 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. Other 1998-12-16

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