MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MOGEN CLAMP; CLAMP, CIRCUMCISION

Model Number MARINA

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Mogen clamp sliced foreskin as it was inserted; due to excessively sharp edges and caused excessive bleeding as it sliced before it could be clamped.Had to apply surgical gauze and statceal powder for hemostasis.

• Brand Name: MOGEN CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 18922220
• MDR Text Key: 338137161
• Report Number: MW5152919
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MARINA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White