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

Catalog Number 330CRK

Device Problem Pressure Problem (3012)

Patient Problem Genital Bleeding (4507)

Event Date 07/23/2023

Event Type  Injury  

Event Description

Bleeding requiring sutures.

Manufacturer Narrative

According to the customer contact, on (b)(6) 2023 a circumcision procedure resulted in "excessive bleeding" which was reportedly due to the clamp.It was reported that due to this, sutures were required and a follow up appointment was done.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: CIRCLAMP W/1.3CM BELL ST - REPROCESSED
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 301 catrell dr,; howell MI 48843
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17596594
• MDR Text Key: 321658618
• Report Number: 1824619-2023-00008
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 330CRK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2023
• 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