MAUDE Adverse Event Report: PREGMATE LLC PREGNANCY AND OVULATION DETECTION STRIPS; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

For clarity, i did not purchase the product.However, i felt obligated to make a report when i came across concerning information.I was reading reviews of the product on (b)(6) and noticed several reviews that indicate the company may be violating the law.The company is called (b)(6) and several reviewers stated they received pregnancy and ovulation tests in (b)(6) bags without proper labels or packaging.It appears they were sent as consideration for the customer making online reviews.Here is a link to one such review: (b)(6).The following comment was made (b)(6) 2019: "update: changed from 5 stars to 1.Tested every day through my ovulation period.Clear signs of ovulation but never got a positive reading in the strip.Will try again using it next month.Also filled out review the first time to ge 25 extra strips.They shipped to me in a regular zip lock bag.Won't be using those since they didn't come in proper packaging." another reviewer wrote "the tests came in a plastic bag" ((b)(6)).(b)(4).

• Brand Name: PREGNANCY AND OVULATION DETECTION STRIPS
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): PREGMATE LLC
• MDR Report Key: 10250231
• MDR Text Key: 198380490
• Report Number: MW5095435
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR