UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-05-29 for UNK manufactured by Johnson & Johnson Medical, Inc..

Event Text Entries

[96502] Service rep alleges developing injuries from prolonged exposure to the fumes of glutaraldehyde.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1618732-1998-00138
MDR Report Key169655
Report Source00
Date Received1998-05-29
Date of Report1998-05-18
Date Mfgr Received1998-05-18
Date Added to Maude1998-06-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameGLUTARALDEHYDE
Product CodeIFT
Date Received1998-05-29
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key165028
ManufacturerJOHNSON & JOHNSON MEDICAL, INC.
Manufacturer Address2500 ARBROOK BLVD. ARLINGTON TX 760143899 US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 1998-05-29

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