MAUDE Adverse Event Report: EVERLYWELL INC. EVERLYWELL COVID-19 HOME COLLECTION KIT; COVID-19 TEST HOME COLLECTION KIT DEVICES

Model Number NOT WRITTEN ON THE PRODUCT

Device Problems Component Incompatible (1108); Peeled/Delaminated (1454); Expiration Date Error (2528); Missing Information (4053)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  malfunction  

Event Description

Everlywell covid-19 test kit label to attach to collection tube is not compatible with ink based pens.When writing a name and dob, the ink smears and or becomes illegible.The other test kit id label is pealing from the collection tube when received.The collection tube or test box do not have a expiry date, lot number, or serialization, presenting a significant risk for patients and contacts due to the potential for inaccurate results.A product compliant reporting mechanism was not readily found with a (b)(6) search or the website from everylwell.Accordingly, pharmacovigilance is significantly underrepresenting risk to patients.The above can be easily verified by obtaining an everlywell covid-19 test kit as well as trying to locate the product compliant hotline.It is recommended the fda conducts an audit of everlywell as these deficiencies likely represent more significant failures within the company requiring action to protect the public.Fda safety report id# (b)(4).

• Brand Name: EVERLYWELL COVID-19 HOME COLLECTION KIT
• Type of Device: COVID-19 TEST HOME COLLECTION KIT DEVICES
• Manufacturer (Section D): EVERLYWELL INC. ; 823 congress ave; austin TX 78701
• MDR Report Key: 11998659
• MDR Text Key: 256454752
• Report Number: MW5101868
• Device Sequence Number: 1
• Product Code: QJR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NOT WRITTEN ON THE PRODUCT
• Device Catalogue Number: NOT WRITTEN ON THE PRODUCT
• Device Lot Number: NOT WRITTEN ON THE PRODUCT
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1