MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE; FORCEPS

Model Number 11.42

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  Injury  

Event Description

The forceps do not close completely.This is part of a disposable laceration kit that is used in the ed.It has been occurring multiple times and it was reported to ed staff.It was being used on a patient at the time of discovery.Fda safety report id # (b)(4).

• Brand Name: MEDLINE
• Type of Device: FORCEPS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD; northfield IL 60093
• MDR Report Key: 13541948
• MDR Text Key: 285728097
• Report Number: MW5107465
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

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 Model Number: 11.42
• Device Lot Number: 21HB0666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention