MAUDE Adverse Event Report: MARINA MEDICAL INSTRUMENTS, INC. MOGEN MARINA; CLAMP, CIRCUMCISION

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

During a routine newborn circumcision, the mogen clamp was too sharp and cut the baby's skin when applied.The mogen clamp should be blunt and should never cut the skin.

• Brand Name: MOGEN MARINA
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MARINA MEDICAL INSTRUMENTS, INC.; 8190 west state rd 84; davie FL 33324
• MDR Report Key: 18922281
• MDR Text Key: 338110777
• Report Number: MW5152921
• 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
• 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: Black Or African American