PLASTIBELL CIRCUMCISION DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for PLASTIBELL CIRCUMCISION DEVICE manufactured by Briggs Medical Service Company.

Event Text Entries

[93752162] During the circumcision when using a plastibell device the tab on the plastibell is snapped off and usually leaves a smooth finish. However, in this case, it didn't snap evenly and caused sharp edges to remain behind. This did not cause patient injury/harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073715
MDR Report Key7079045
Date Received2017-12-01
Date of Report2017-11-29
Date of Event2017-11-11
Date Added to Maude2017-12-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePLASTIBELL CIRCUMCISION DEVICE
Generic NameBELL, CIRCUMCISION
Product CodeHFX
Date Received2017-12-01
Lot Number5D06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBRIGGS MEDICAL SERVICE COMPANY
Manufacturer AddressWAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-01

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