LEICA RM2255 1492255UL01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-13 for LEICA RM2255 1492255UL01 manufactured by Leica Biosystems Nussloch.

MAUDE Entry Details

Report Number1423337-2019-00007
MDR Report Key8696842
Date Received2019-06-13
Date of Report2019-08-16
Date of Event2019-04-29
Date Facility Aware2019-05-14
Report Date2019-08-16
Date Reported to FDA2019-08-16
Date Reported to Mfgr2019-08-16
Date Added to Maude2019-06-13
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEICA RM2255
Generic NameLEICA RM2255
Product CodeIDO
Date Received2019-06-13
Model Number1492255UL01
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLEICA BIOSYSTEMS NUSSLOCH
Manufacturer AddressHEIDELBERGER STRASSE 17-19 NUSSLOCH, 69226 GM 69226


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-13

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