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

Model Number	DYNDF1072A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During circumcision, metal shavings flaked off the hemostats, from medline industries, inc.Circumcision tray, to the patient during a sterile procedure.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CIRCUMCISION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12335830
• Report Number: 12335830
• Device Sequence Number: 3391836
• 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): 08/10/2021
• Report Date (Section F): 08/10/2021

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: No Information
• Device Model Number: DYNDF1072A
• Device Catalogue Number: DYNDF1072A
• Device Lot Number: 21EBB656
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2021
• Patient Sequence Number: 1
• Patient Weight: 4
• Date Report Sent to FDA: 08/10/2021