MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number MDS99508

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

The medline 30-second oral digital stick thermometer appears to give an accurate reading during the first use.However, they show a temperature reading of 91 fahrenheit degrees for all subsequent temperatures.The staff is having this issue with the second reading of 91 fahrenheit degrees repeatedly for most patients.

• Brand Name: MEDLINE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11169675
• MDR Text Key: 226784238
• Report Number: 11169675
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2021

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
• Device Operator: No Information
• Device Catalogue Number: MDS99508
• Device Lot Number: L191230002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Date Report to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1