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

Model Number 310CR

Device Problem Defective Component (2292)

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.A recall associated with this lot had already been initiated prior to the receipt of this complaint.

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: 9842270
• MDR Text Key: 190937220
• Report Number: 1824619-2020-00003
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 00653160197471
• UDI-Public: (01)00653160197471(10)2019061801(17)240331
• 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

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 310CR
• Device Lot Number: 2019061801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2020
• 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