MAUDE Adverse Event Report: WALGREENS INFRARED INSTANT EAR DIGITAL THERMOMETER

Model Number 31191715997

Device Problems Defective Component (2292); Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

"providing goods that are substandard or defective" (b)(6) manufactures a defective thermometer resulting in inaccurate low readings.Internal review resulted in discontinuing distribution from the manufacturer.However (b)(6) has not voluntarily recalled the device or report the faulty device to the fda.(b)(6) has not removed the device from shelves or online.The price of the thermometer has been greatly reduced.In an attempt to quickly unload the inventory and turn a profit while they still can.In good faith i have followed the chain of command to allow (b)(6) to utilize the system of safe reporting and maintain a high level of integrity.Customer complaints are documented back 2 years before i got involved.I believe that the sale of a defective thermometer with low readings caused unnecessary pediatric admissions to the emergency department and unnecessary doctor visits.Cms payouts on uncontrolled fever claims, medication management discharged patients with otc prescription for tylenol filled at (b)(6) pharmacies is evident of a revolving door of patients and sales.Reducing the price to force these thermometers into use for pediatric patients is beyond deplorable, unethical and illegal.I believe after a review of the documentation (b)(6) is responsible to cover the cost the cms paid out in uncontrolled fever claims in relation to the amount of devices that were produced.Most importantly (b)(6) needs to follow the laws to safe reporting and pull the item from shelves and online marketplace.Diagnosis or reason for use: false low readings.(b)(6).

• Brand Name: WALGREENS INFRARED INSTANT EAR DIGITAL THERMOMETER
• Type of Device: WALGREENS INFRARED INSTANT EAR DIGITAL THERMOMETER
• MDR Report Key: 7464829
• MDR Text Key: 106839045
• Report Number: MW5076795
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31191715997
• Device Lot Number: 1701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization