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

Model Number DYNDF1117

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Event 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.
• Type of Device: CIRCUMCISION KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7605228
• MDR Text Key: 111195706
• Report Number: 7605228
• Device Sequence Number: 1
• Product Code: HFX
• UDI-Device Identifier: 10884389797884
• UDI-Public: (01)10884389797884
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Model Number: DYNDF1117
• Device Catalogue Number: DYNDF1117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1