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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Filing for initial report, investigation is ongoing.

Event Description

Circlamp removed foreskin without the use of scalpel.

Manufacturer Narrative

The initial report from the customer stated the device involved was from a different provider.As the device was not returned and no information related to the device code or lot number was available, we are unable to confirm the device was manufactured by centurion.

• Brand Name: CENTUION CIRCLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston, mi
• MDR Report Key: 9890573
• MDR Text Key: 190937479
• Report Number: 1824619-2020-00005
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other