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

Device Problem Failure to Align (2522)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2019

Event Type  malfunction  

Event Description

Patient a.New born boy had circumcision w/1.1 with heavy bleeding pedi-cauterized to control.No device retained.Patient b.New born boy had circumcision w/1.3 cm centurion circlam bell in place but rest of device would not line up.Baby fine.A new device was opened and used.

• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 3310 s main st; salisbury NC 28147
• MDR Report Key: 9859690
• MDR Text Key: 184280118
• Report Number: 9859690
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/05/2020,02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Weight: 3