MAUDE Adverse Event Report: TARGET CORPORATION TARGET OVULATION TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problems False Negative Result (1225); Defective Device (2588)

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

Event Date 02/05/2023

Event Type  malfunction  

Event Description

Target brand's ovulation test kits are faulty.Some had no indicator line, and others gave me false negatives (confirmed by different results on better-quality tests).You can see the online reviews on their own website, where 40% of women give it 1 star and most of them had the same experience as me.They shouldn't be allowed to sell a health product with reliability this poor.Https://www.Target.Com/p/ovulation-pregnancy-test-combo-pack-11ct-up-38-up-8482/-/a- 78261584.

• Brand Name: TARGET OVULATION TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): TARGET CORPORATION
• MDR Report Key: 16380668
• MDR Text Key: 309769512
• Report Number: MW5114964
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/11/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White