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

Model Number 330CRK

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

Circumcision clamp was opened and checked.Metal slivers were found to come off the base plate when wiped with gauze.

• Brand Name: CENTURION
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 10378264
• MDR Text Key: 202055252
• Report Number: 10378264
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 330CRK
• Device Lot Number: 2020012301
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Type of Device Usage: N
• Patient Sequence Number: 1