CIRCLAMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for CIRCLAMP manufactured by Centurion Medical Products Corporation.

Event Text Entries

[178579735] Circ bell was tightened and the foreskin was almost completely cut off d/t sharpness of the instrument. Premie baby boy 3 weeks early. Chart review indicates no subsequent concerns r/t circumcision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9693540
MDR Report Key9693540
Date Received2020-02-11
Date of Report2020-01-15
Date of Event2019-08-01
Report Date2020-01-15
Date Reported to FDA2020-01-15
Date Reported to Mfgr2020-02-11
Date Added to Maude2020-02-11
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 NameCIRCLAMP
Generic NameCLAMP, CIRCUMCISION
Product CodeHFX
Date Received2020-02-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCENTURION MEDICAL PRODUCTS CORPORATION
Manufacturer Address301 CATRELL DR HOWELL MI 48843 US 48843


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-11

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