MAUDE Adverse Event Report: ACCUMED PREGNANCY TEST STRIPS; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Establishment: (b)(4).Accumed is currently abusing the fda logo for marketing/consumer gains.They have currently placed fda's logo onto their packaging for hcg pregnancy test strips.Accumed biotech.Fda safety report id# (b)(4).

• Brand Name: ACCUMED PREGNANCY TEST STRIPS
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 12780711
• MDR Text Key: 280712016
• Report Number: MW5105218
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/04/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male