*

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 2007-12-20 for * manufactured by Karl Storz Endovision, Inc..

MAUDE Entry Details

Report Number1221826-2007-00034
MDR Report Key980538
Report Source06
Date Received2007-12-20
Date Added to Maude2008-01-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer Street91 CARPENTER HILL RD
Manufacturer CityCHARLTON MA 01507
Manufacturer CountryUS
Manufacturer Postal01507
Manufacturer Phone*
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic Name*
Product CodeFFZ
Date Received2007-12-20
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key948222
ManufacturerKARL STORZ ENDOVISION, INC.
Manufacturer Address91 CARPENTER HILL RD. CHARLTON MA 015075256 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-12-20

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