MAUDE Adverse Event Report: V. MUELLER MOGEN CLAMP

Model Number GL 7021

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/21/2014

Event Type  Injury  

Event Description

Mogen clamp used during circumcision; tip of penis transected.Tip of penis was amputated; required transfer and surgery to reattach.

• Brand Name: MOGEN CLAMP
• Type of Device: MOGEN CLAMP
• Manufacturer (Section D): V. MUELLER; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 4232132
• MDR Text Key: 20975631
• Report Number: 4232132
• Device Sequence Number: 1
• Product Code: HFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

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
• Device Model Number: GL 7021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2014
• Distributor Facility Aware Date: 09/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 DA
• Patient Weight: 2