CRILE V. MUELLER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for CRILE V. MUELLER manufactured by Mckesson Technologies, Inc..

Event Text Entries

[120415018] During surgery the tip of the kelly clamp broke off 1 inch. Identified immediately. No fb (foreign body) retained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7880813
MDR Report Key7880813
Date Received2018-09-17
Date of Report2018-09-11
Date of Event2018-08-16
Report Date2018-09-11
Date Reported to FDA2018-09-11
Date Reported to Mfgr2018-09-17
Date Added to Maude2018-09-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRILE V. MUELLER
Generic NameSURGICAL CLAMP
Product CodeGDJ
Date Received2018-09-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMCKESSON TECHNOLOGIES, INC.
Manufacturer Address220 DAVIDSON AVE SOMERSET NJ 08873 US 08873


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-17

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