MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORP. CENTURION CIRCUMCISION TRAY NEWBORN NURSERY CIT6610AS

Model Number CIT6610AS

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

The hemostat that came in the centurion circumcision tray newborn nursery kit malfunctioned during pt's circumcision.The hemostat became stuck while it was clamped on the foreskin during circumcision.Provider unable to unclamp hemostat requiring to cut foreskin around hemostat to remove.Fda safety report id # (b)(4).

• Brand Name: CENTURION CIRCUMCISION TRAY NEWBORN NURSERY CIT6610AS
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORP.; williamston MI 48895
• MDR Report Key: 12032088
• MDR Text Key: 257448687
• Report Number: MW5101966
• Device Sequence Number: 1
• Product Code: OHG
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIT6610AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 4