MAUDE Adverse Event Report: CENTURION; CIRCLAMP W/1.3CM BELL ST

Catalog Number 330CRK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility post circumcision bleeding was noted "around the 30-minute check".Per the facility "the bleeding was noted on the ventral dorsal side of the penis by the frenulum requiring the nurse to apply pressure, gel foam, vaseline and gauze to the affected area".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility post circumcision bleeding was noted "around the 30-minute check".

• Type of Device: CIRCLAMP W/1.3CM BELL ST
• Manufacturer (Section D): CENTURION; 301 catrell dr; howell MI 48843 1703
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17059167
• MDR Text Key: 316503586
• Report Number: 1824619-2023-00006
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 330CRK
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other