MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS, LP CENTURION CLAMP; CIRCUMCISION TRAY

Model Number CIT5935A

Device Problems Disconnection (1171); Product Quality Problem (1506); Material Separation (1562); Failure to Obtain Sample (2533)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2023

Event Type  malfunction  

Event Description

Circumcision clamp popping off, will not retain tissue as intended/designed.

• Brand Name: CENTURION CLAMP
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS, LP
• MDR Report Key: 17351408
• MDR Text Key: 319395911
• Report Number: MW5119589
• Device Sequence Number: 1
• Product Code: OHG
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIT5935A
• Device Catalogue Number: CIT5935A
• Device Lot Number: 23ABQ559
• 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 Age: 1 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White