MAUDE Adverse Event Report: MOGEN CIRCUMCISION CLAMP

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Physical Entrapment (2327)

Event Date 08/10/1989

Event Type  Injury  

Event Description

I suffered partial amputation of the glans penis during mogen clamp circumcision.A portion of the glans became entrapped in the device and was amputated when the clamp was locked.

• Brand Name: MOGEN CIRCUMCISION CLAMP
• Type of Device: CIRCUMCISION CLAMP
• MDR Report Key: 4643413
• MDR Text Key: 5595608
• Report Number: MW5041689
• Device Sequence Number: 1
• Product Code: HFX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 2 YR
• Patient Weight: 3