MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS, LP; CIRCLAMP W/1.3CM BELL ST - REPROCESSED

Catalog Number 330CRK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

According to the customer on 3/15/2024, "circlamp was used for male circumcision and surgicel was applied to stop excessive bleeding.Surgery was not required".The product is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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 customer on 3/15/2024, "circlamp was used for male circumcision and surgicel was applied to stop excessive bleeding.Surgery was not required".

• Type of Device: CIRCLAMP W/1.3CM BELL ST - REPROCESSED
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS, LP; 301 catrell drive; howell MI 48843 1703
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19124649
• MDR Text Key: 340379106
• Report Number: 1824619-2024-00006
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 10653160309901
• UDI-Public: 10653160309901
• 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: 04/17/2024

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 Catalogue Number: 330CRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other