OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE A22026A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-18 for OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE A22026A manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

Report Number2951238-2019-01017
MDR Report Key8804572
Date Received2019-07-18
Date of Report2019-07-18
Date Facility Aware2019-06-21
Report Date2019-06-21
Date Reported to Mfgr2019-06-21
Date Added to Maude2019-07-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 NameOUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
Generic NameOUTER SHEATH
Product CodeGCP
Date Received2019-07-18
Model NumberA22026A
Catalog NumberA22026A
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-18

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