MAUDE Adverse Event Report: CENTURION MEDICLA PRODUCTS CENTURION CIRCLAMP; HFX; CLAMP, CIRCUMCISION

Model Number 245CR

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/27/2014

Event Type  Injury  

Event Description

Circumcision performed with 1.45cm gomco (circlamp).Gomco (circlamp) placed and after cutting foreskin the bell slid off the head of penis.Large amount of foreskin was removed form shaft of penis.Large amount of bleeding noted.Silver nitrate used, but required sutures to stop bleeding.

• Brand Name: CENTURION CIRCLAMP
• Type of Device: HFX; CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICLA PRODUCTS; howell MI
• Manufacturer (Section G): CENTURION MEDICAL PRODUCTS; howell MI 48843
• Manufacturer Contact: matthew price ; 100 centurion way; williamston, MI 48895 ; 5175451135
• MDR Report Key: 4249678
• MDR Text Key: 5050092
• Report Number: 1824619-2014-00002
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 245CR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA