MAUDE Adverse Event Report: VALLEY ELECTRONICS AG DAYSY; DAYSY FERTILITY TRACKER

Lot Number 12-2018

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Fungal Infection (2419)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

There were no such cases reported or known to the manufacturer in the past.Per the patient, she was using the days device daily since she purchased days in (b)(6) 2019.Most likely, there was no contamination from production or transportation, since candida is present in the mouth of humans.The patient stated that she was not cleaning the device between use (the ifu states that it should be cleaned).The user provided photos showing there was no physical damage to the device specifically the tip of the sensor being in contact with the mucus.Hence, the device most likely did not cause micro lesions due to sharp edges.Also, there were no dirt particles visible in the pictures.Furthermore, the patient stated to have discomfort while using the device before the adverse event.After request she confirmed to have overinserted the device (ifu warns not to overinsert the device) and suspects this to be the root cause for the oral thrush.To this point it is unclear whether or not untreated candidiasis may lead to systemic candidiasis potentially putting the patient into a situation of serious injury meaning permanent damage to a body function or part.Our report is past the 30 day reporting mark due delays in getting a functioning production account for the esubmitter/web trader.

Event Description

Patient experienced discomfort at spot in mouth where daily temperature measuring occurred and developed thrush.Medicine was prescribed by patients doctor.Patient went to her doctor for the thrush and was prescribed nystatin oral suspension and diflucan 2 pills to cure the fungal infection (candidiasis) in her mouth.Patient is currently in good and healthy condition.

• Brand Name: DAYSY
• Type of Device: DAYSY FERTILITY TRACKER
• Manufacturer (Section D): VALLEY ELECTRONICS AG; marienstrasse 16; zurich, 8003 ; SZ 8003
• Manufacturer (Section G): VALLEY ELECTRONICS AG; marienstrasse 16; zurich, 8003 ; SZ 8003
• Manufacturer Contact: niklas nathe ; marienstrasse 16; zurich, 8003 ; SZ 8003
• MDR Report Key: 9205972
• MDR Text Key: 163166868
• Report Number: 3011197658-2019-00001
• Device Sequence Number: 1
• Product Code: LHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2019,09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 12-2018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2019
• Distributor Facility Aware Date: 08/27/2019
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 09/24/2019
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 60