MAUDE Adverse Event Report: ELMED INC. MOGEN CLAMP CIRCUMCISION CLAMP; CLAMP, CIRCUMCISION

Catalog Number 2155 OR 3155

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Physician performed circumcision using mogen clamp.When he released the clamp, he had amputated the head of glans penis with urethra.Fda safety report id #: (b)(4).

• Brand Name: MOGEN CLAMP CIRCUMCISION CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ELMED INC.; 35 n brandon dr; glendale heights IL 60139
• MDR Report Key: 10179996
• MDR Text Key: 196154920
• Report Number: MW5095141
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2155 OR 3155
• Device Lot Number: E0220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 1 DA