MAUDE Adverse Event Report: MOGEN CLAMP; CLAMP, CIRCUMCISION

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 07/19/2020

Event Type  Injury  

Event Description

Removal of skin tissue; during a circumcision procedure , this device was used to clamp the foreskin to apply hemostasis.Instead, the device popped off and lacerated the tissue, subsequently removing the tissue with it; koenig.

• Brand Name: MOGEN CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 10431317
• MDR Text Key: 203857691
• Report Number: MW5096158
• 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: Other
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Weight: 3