WELL AT WALGREENS ITEM 990442

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for WELL AT WALGREENS ITEM 990442 manufactured by Walgreens Co..

Event Text Entries

[109226939] The walgreen's brand analog ultra pregnancy tests compared to "clearblue plus pregnancy test"is giving false positives with every use and test! I (among many, many women who are struggling with infertility) become very upset and disappointed when we finally get a positive pregnancy test just to have it confirmed by a doctor that we are not pregnant. I have read every review on walgreen's website about this product and every review was about how they, too, in fact used this test and was given a false positive. The damage these tests are doing to us women can become so catastrophic that it can cause women to harm themselves because they suffer from depression and seeing a false positive on a test that holds their entire hopes and dreams to just be a lie a devastating to say the least. I have read that many, many women have already reported this issue to walgreen's and the number provided on the back of the box, all for these tests to still be on the shelves causing more and more women to have false hope! This issue has got to be fixed. Walgreen's can not put something on their shelves that is a complete lie and giving false results, especially when it comes to tests! With all of the reviews and complaints already been and being made against this, i'm surprised these are still being sold! I will be calling the number on the back to get a full refund as soon as i'm done with this report. I still have the product in my possession: yes. May we include your report, including any documents or photographs that you have attached to your report, but without your name and contact information, in cpsc's public database: yes, you may include my report with any attachments on (b)(4). I certify that i have reviewed the report and that the information provided in this report is true and accurate to the best of my knowledge, information, and belief. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077405
MDR Report Key7536869
Date Received2018-05-22
Date of Report2018-05-12
Date of Event2018-05-11
Date Added to Maude2018-05-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameWELL AT WALGREENS
Generic NamePREGNANCY TEST. WALGREENS BRAND "COMPARE TO CLEARBLUE PLUS PREGNANCY TEST". WALG
Product CodeLCX
Date Received2018-05-22
Model NumberITEM 990442
Lot NumberC11601
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerWALGREENS CO.
Manufacturer Address200 WILMOT RD MS# 2002 DEERFIELD IL 60015 US 60015

Device Sequence Number: 1

Brand NameWELL AT WALGREENS
Generic NamePREGNANCY TEST. WALGREENS BRAND "COMPARE TO CLEARBLUE PLUS PREGNANCY TEST". WALG
Product CodeLCX
Date Received2018-05-22
Model NumberITEM 990442
Lot NumberC11601
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerWALGREENS CO.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-22

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