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 06/06/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2023 a "circumcision outcome with lots of bleeding and six sutures needed".The customer reported the "gomco did not maintain hemostasis" which resulted in the patient requiring six sutures.No additional injury or medical intervention was reported related to the incident.The 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.

Event Description

Circumcision requiring sutures.

• 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: 17299137
• MDR Text Key: 318925941
• Report Number: 1824619-2023-00007
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 330CRK
• Device Lot Number: 2023010901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Date Manufacturer Received: 06/16/2023
• 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