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

Model Number DYNDF1072A

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

Scissors, from medline circumcision tray, reported as dull per pediatrician.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 11715621
• MDR Text Key: 246986760
• Report Number: 11715621
• Device Sequence Number: 1
• Product Code: OHG
• UDI-Device Identifier: 10884389542040
• UDI-Public: (01)10884389542040
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDF1072A
• Device Catalogue Number: DYNDF1072A
• Device Lot Number: 21ABN726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Date Report to Manufacturer: 04/23/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1