inforMED
MalfunctionLCX

CVSHEALTH EARLY RESULT PREGNANCY TEST

Received Mar 7, 2023 · Event occurred Mar 2, 2023

Report MW5115494 · MDR key 16501324

Device

Generic name

Kit, Test, Pregnancy, Hcg, Over The Counter

Manufacturer

Unk

Catalog number

000233-12 9/21

Lot number

10121496

Product problems

  • Product Quality Problem
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

16 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON (B)(6) 2023, I PURCHASED CVS HEALTH EARLY RESULT PREGNANCY TEST, 2 TEST STICKS. MY 16 Y.O. DAUGHTER MUST SHOW A NEGATIVE PREGNANCY RESULT TEST IN ORDER TO START THE 30-DAYS IPLEDGE PROGRAM TO USE ACCUTANE. AFTER URINATING ON THE ABSORBENT TIP AND FOLLOWED THE PACKAGE INSTRUCTION, BOTH STICKS GAVE AN INVALID RESULT BECAUSE NO LINE APPEARS IN THE CONTROL WINDOW. I RETURNED TO CVS AND PURCHASED ANOTHER BOX OF THE SAME BRAND, AGAIN 2 STICKS RESULTED IN INVALID. BOTH BOXES THAT WERE PURCHASED HAVE LOT NO: 10121496. EXPIRE DATE=2025-11-30. CVS HEALTH DOES NOT HAVE A CONSUMER PRODUCT COMPLAIN ONLINE NOR A PHONE NUMBER TO CONTACT. REFERENCE REPORT #MW5115492, #MW5115493, #MW5115495.