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

Device Problem Sharp Edges (4013)

Patient Problem No Code Available (3191)

Event Date 08/01/2019

Event Type  malfunction  

Event Description

Circ bell was tightened and the foreskin was almost completely cut off d/t sharpness of the instrument.Premie baby boy 3 weeks early.Chart review indicates no subsequent concerns r/t circumcision.

• Brand Name: CIRCLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 9693540
• MDR Text Key: 178579735
• Report Number: 9693540
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA
• Patient Weight: 3