MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION CIRCLAMP; CIRCUMCISION CLAMP

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Based on the information available, no patient injury occurred.This event is being reported based on its similarity to a previous submission.Additionally, it should be noted that a recall associated with this issue had already been initiated prior to the receipt of this complaint.However, as a lot number was not reported and no sample was available, we are unable to determine if the device used in this report is included in the recalled lots.

Event Description

Circlamp removed foreskin without the use of scalpel.

• Brand Name: CENTURION CIRCLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• Manufacturer (Section G): CENTURION MEDICAL PRODUCTS; 301 catrell dr; howell, mi
• Manufacturer Contact: karen kowalczyk ; 100 centurion way; williamston, mi ; 5451122
• MDR Report Key: 9842269
• MDR Text Key: 190937180
• Report Number: 1824619-2020-00002
• 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: other
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/17/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/17/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA
• Patient Weight: 3