WALGREENS PREGNANCY TEST SHP 1038/3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-09 for WALGREENS PREGNANCY TEST SHP 1038/3 manufactured by Walgreens Co..

Event Text Entries

[46714768] I am writing to report a defective pregnancy test kit ((b)(6) pregnancy test, 2 applicators per box). Both applicators failed to exhibit the positive control band. I tried the product in the afternoon of (b)(6) 2016 and then the following morning ((b)(6) 2016), following the instructions on the box and in the package insert. Info on the product foil cover: (b)(4). I purchased the product at a (b)(6). When i attempted to contact (b)(6) by their online reporting process (https://www. (b)(6). Com/mktg/contactus/contact-us-forms. Jsp? Tier3id=1225), the website appeared to be malfunctioning as the page became stalled after i pressed the "submit" button. All of the data fields on the page were filled in, but i am concerned that (b)(6) is unable to address product problems or product complaints if they are unable to receive messages from consumers. This was my attempted message: "both applicators failed to exhibit a positive control band. I followed the directions on the box and the package insert. The codes on the test applicator: (b)(4). I bought the box at a (b)(6). Please f/u with your complaints department regarding this product failure and let me know what the response is. (b)(6)". I also looked up consumer comments on the product and saw a complaint that mirrored my own (albeit with the single device package presentation. "positive but with no control line in the results box? I'll take another better test in a couple days and see what i think. " http://www. (b)(6). Com/store/c/(b)(6)-one-step-pregnancy-test/id=prod6188716-product? Ext=goopla_-sexual_wellness_mobile%pla&adtype=pla&kpid=sku6166560&sst=f39b355a-be8a-41al-8a99-5f8c2b22b3a5.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062223
MDR Report Key5649772
Date Received2016-05-09
Date of Report2016-05-09
Date of Event2016-05-08
Date Added to Maude2016-05-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWALGREENS PREGNANCY TEST
Generic NameWALGREENS PREGNANCY TEST
Product CodeLCX
Date Received2016-05-09
Model NumberSHP 1038/3
Lot NumberP/N=PL0009
Device Expiration Date2018-08-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWALGREENS CO.


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-09

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