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

Model Number	310CR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During circumcision: no hemostasis, no closing - clamp removed the foreskin.Centurion was used to circumcise infant by doctor when she closed the clamp, instead of just providing hemostasis, it removed the foreskin from the penis.

• Brand Name: CENTURION
• Common Device Name: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 9693510
• Report Number: 9693510
• Device Sequence Number: 11368379
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/15/2020
• Report Date (Section F): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 310CR
• Device Catalogue Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Weight: 3
• Date Report Sent to FDA: 01/15/2020