MAUDE Adverse Event Report: UNKNOWN ORAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

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

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

Event Date 06/10/2020

Event Type  malfunction  

Event Description

Please be advised that after purchasing four defective (b)(6) oral thermometers and two defective infrared thermometers, all consistently low incorrect readings from.8 to 1.3 degrees fahrenheit, i became concerned that my monitoring my chronically disabled and sick wife's temperature could seriously injure her.I itemized my complaints to the ftc regarding (b)(6) credibility, legal liability, poor business practices, and qualifications to sell medical equipment from unknown, non inspected, off shore manufacturers.Most thermometers had no brand name on (b)(6) promotional website.The (b)(6) representatives (b)(6) had heavy accents and inadequate training.(b)(6) slightly better but brittle abrupt attitude.(b)(6) a blessed relief.Thank you very much.(b)(6).Please help me: where and what brand name can i purchase an "accurate" oral and infrared thermometer? i have photographs.Seller, (b)(6) has been notified on returned product.Fda safety report id #: (b)(4).

• Brand Name: ORAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10173860
• MDR Text Key: 196065926
• Report Number: MW5095083
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/16/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 84