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

Model Number 330CRK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 02/22/2020

Event Type  Injury  

Manufacturer Narrative

Filing for initial report, investigation is ongoing.

Event Description

Abrasion of the skin resulting in bleeding that required sutures.

• 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,
• Manufacturer Contact: karen kowalczyk ; 100 centurion way; williamston, mi ; 5451122
• MDR Report Key: 9886256
• MDR Text Key: 190936615
• Report Number: 1824619-2020-00004
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 10653160309901
• UDI-Public: (01)10653160309901(10)2019110601(17)240630
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 330CRK
• Device Lot Number: 2019110601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention