MAUDE Adverse Event Report: SAMSUNG MEDISON CO., LTD. SAMSUNG GALAXY WATCH 5; DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION

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

Event Date 12/10/2023

Event Type  malfunction  

Event Description

I purchased a samsung galaxy watch 5 which had fda approval to advertise its menstrual cycle prediction feature by utilizing skin temperature while sleeping.The watch and app report conflicting data and the predictions have never been accurate.On november 29th, i contacted samsung health about my issues with the medical device and digital application.I have been in contact with them the past two weeks.They have been unable to troubleshoot and resolve any of the issues.I left a review on the app store and they requested i delete my data to troubleshoot and were unable to reach a resolution.Now i don't have any data at all.To inform about fertility decisions.

• Brand Name: SAMSUNG GALAXY WATCH 5
• Type of Device: DEVICE, FERTILITY DIAGNOSTIC, CONTRACEPTIVE, SOFTWARE APPLICATION
• Manufacturer (Section D): SAMSUNG MEDISON CO., LTD.; 244, 1gongdan-ro; gumi-si gyeongbuk 39376 ; KS 39376
• MDR Report Key: 18326193
• MDR Text Key: 330639869
• Report Number: MW5149240
• Device Sequence Number: 1
• Product Code: PYT
• Combination Product (y/n): Y
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Race: White