YELLEN CLAMP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-11 for YELLEN CLAMP * manufactured by Unk.

Event Text Entries

[17804140] The pt received circumcision. The procedure was performed in standard fashion without complication. The pt was observred for 15 minutes after the procedure as per standard practice. At the 15 minute check active bleeding was noted. Direct pressure was applied but bleeding continued after release. A single superficial bleeding artery was isolated and ligated with 5-0 vicryl with complete resolution of bleeding.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1031208
MDR Report Key513123
Date Received2004-02-11
Date of Report2004-02-11
Date Added to Maude2004-02-27
Event Key0
Report Source CodeVoluntary 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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameYELLEN CLAMP
Generic NameCIRCUMCISION KIT
Product CodeHFX
Date Received2004-02-11
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key502133
ManufacturerUNK
Manufacturer AddressUNK UNK *

Device Sequence Number: 2

Brand Name1.45 GOMCO BELL
Generic NameCIRCUMCISION KIT
Product CodeFHG
Date Received2004-02-11
Model Number*
Catalog Number*
Lot Number*
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key502436
ManufacturerUNK
Manufacturer AddressUNK UNK *

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-02-11
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