MAUDE Adverse Event Report: AMERICAN SCREENING CORPORATION DIGITAL THERMOMETER; THERMOMETER KIT

Catalog Number SKU: IP-KFT02

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

I placed an order for a fever thermometer with american screening corp (asc) on (b)(6) 2020 via the internet.After receipt around (b)(6) and upon examination of the product i decided to return the thermometer.As shown in the photograph, the product arrived rolled in bubble wrap.The thermometer itself was in a plastic case inside a plastic bag.There was no accompanying written material describing how to use the thermometer.There was no identification of the manufacturer.Without manufacturer documentation for traceability, i could not determine if this thermometer were new or used.I did receive advertising literature in the order.The literature advertised asc's drug screening and background checking services.I have sent emails three times to the asc's company customer email address requesting return of the product and refund.The last was sent on (b)(6) 2021.All emails have been ignored.Suspecting this company to be fraudulent i checked the better business bureau (bbb) in (b)(6), where asc is located.The bbb revoked asc's accreditation on 06/10/2020.I am filing this fda report because this medical device, a thermometer, was sold to me without documentation for use nor identification of the manufacturer.Thus, as well, i cannot determine if it is new or used.Fda safety report id# (b)(4).

• Brand Name: DIGITAL THERMOMETER
• Type of Device: THERMOMETER KIT
• Manufacturer (Section D): AMERICAN SCREENING CORPORATION
• MDR Report Key: 11462221
• MDR Text Key: 239745981
• Report Number: MW5099917
• Device Sequence Number: 1
• Product Code: PXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2021

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: SKU: IP-KFT02
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2021
• 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 Age: 77 YR
• Patient Weight: 87