MAUDE Adverse Event Report: FETAL HEART MONITOR; ANALYZER, DATA, OBSTETRIC

Device Problem Nonstandard Device (1420)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/28/2021

Event Type  Injury  

Event Description

Miscarriage; i didn't know there was a recall on this product and has been using it with my fetal heart monitor.And then i found out at about 20/21 weeks that i had lost my baby.That date was (b)(6) 2021.I then had to deliver her and deal with all that.Factor 5 blood clot disorder.Fda safety report id # (b)(4).

• Brand Name: FETAL HEART MONITOR
• Type of Device: ANALYZER, DATA, OBSTETRIC
• MDR Report Key: 12294853
• MDR Text Key: 265622184
• Report Number: MW5103102
• Device Sequence Number: 1
• Product Code: HEO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR