MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CIRCUMCISION TRAY

Model Number	DYNDF1072A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Health care provider reported hemostat did not clamp correctly, there was a gap in the instrument.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CIRCUMCISION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11723433
• Report Number: 11723433
• Device Sequence Number: 3647178
• Product Code: OHG
• UDI-Device Identifier: 10884389542040
• UDI-Public: (01)10884389542040
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021
• Report Date (Section F): 04/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: DYNDF1072A
• Device Catalogue Number: DYNDF1072A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1
• Patient Weight: 4
• Date Report Sent to FDA: 04/16/2021