FACELAKE FL-100B HEARTBEAT BABY MONITOR SOUND LISTENING TOOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for FACELAKE FL-100B HEARTBEAT BABY MONITOR SOUND LISTENING TOOL manufactured by Contec Medical System.

Event Text Entries

[105758400] My sister purchased a fetal doppler (facelake fl-100b heartbeat baby monitor sound listening tool, listening to the sounds your baby makes) on (b)(6). Upon using the device on my wife we immediately realized that the device was malfunctioning and started heating up and burned my wife's tissue around the belly. We immediately stopped using the product and sought medical attention. We went to a nearby hospital and the specialist on duty strongly advised against the use of facelake fl-100b heartbeat monitor and asked us to proceed with a report on this website. The doctor also advised us about the potential hazard of this product and harm it can cause. He also indicated that this was a professional product only designed to be used by a licensed practitioner and shouldn't have been sold without a prescription. Only then we realized that this is a prescription medical device. The burn was minimal and the doctor stated that this is not normal with a fetal doppler and shouldn't happen. He wasn't sure why this caused a burn. I am not sure why (b)(6) is selling these products and makes it readily available to the public without doctor's consent. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5076504
• MDR Report Key: 7432355
• Date Received: 2018-04-13
• Date of Report: 2018-04-13
• Date of Event: 2018-04-08
• Date Added to Maude: 2018-04-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: FACELAKE FL-100B HEARTBEAT BABY MONITOR SOUND LISTENING TOOL
• Generic Name: DOPPLER, FETAL
• Product Code: KNG
• Date Received: 2018-04-13
• Model Number: FACELAKE FL-100B
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONTEC MEDICAL SYSTEM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2018-04-13