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

Model Number	DYNDF1117
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the hemostat in the circumcision kit was extremely sharp and would have pierced the patient's penis had it been used.This has occurred on several occasions and requires the physicians to retrieve another hemostat.Some of the hemostats are more blunt than others.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CIRCUMCISION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7605228
• Report Number: 7605228
• Device Sequence Number: 1695078
• Product Code: HFX
• UDI-Device Identifier: 10884389797884
• UDI-Public: (01)10884389797884
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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: Physician
• Device Model Number: DYNDF1117
• Device Catalogue Number: DYNDF1117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018