MAUDE Adverse Event Report: MOGEN CLAMP

MOGEN CLAMP

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Device Problem Fail-Safe Design Failure (1222)

Patient Problem Laceration(s) (1946)

Event Date 12/16/2016

Event Type Injury

Event Description

Circumcision with mogen clamp; distal end of glans of penis lacerated - cut off.

1 Device was Involved in the Event
Brand Name	MOGEN CLAMP
Type of Device	MOGEN
MDR Report Key	6217990
MDR Text Key	63817219
Report Number	MW5067020
Device Sequence Number	1
Product Code	HFX
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Voluntary
Reporter Occupation	Other Health Care Professional
Type of Report	Initial
Report Date	12/29/2016
1 Patient was Involved in the Event
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	Health Professional
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	Yes
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	12/29/2016
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Required Intervention;
Patient Age	1 YR
Patient Weight	5