CAREFUSION CIRCUMCISION TRAY OB-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for CAREFUSION CIRCUMCISION TRAY OB-100 manufactured by Carefusion.

Event Text Entries

[182543820] Hemostat would not grip the tissue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093540
MDR Report Key9793397
Date Received2020-03-04
Date of Report2020-03-02
Date of Event2020-02-25
Date Added to Maude2020-03-05
Event Key0
Report Source CodeVoluntary 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 NameCAREFUSION CIRCUMCISION TRAY OB-100
Generic NameCLAMP, CIRCUMCISION
Product CodeHFX
Date Received2020-03-04
Lot Number0001328893
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer AddressVERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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