MAUDE Adverse Event Report: MALEM MEDICAL/ BEDWETTING STORE MALEM BEDWETTING ALARM

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Electric Shock (2554)

Event Type  Injury  

Event Description

The malem bedwetting alarm shocked my child.The alarm unit malfunctioned and my son received shocks for almost a minute.He was in severe pain and yelled so loud that i still can't forget his cry.This product has a manufacturing defect and needs to be pulled from the us market.When i tried and tested the alarm for the second time in my hand, the moment i inserted the battery the alarm produced a strong shock.This product should be recalled and banned from the us market permanently.This is a dangerous medical product that can be life threatening to anyone using it.Fyi, i purchased this alarm from (b)(6) and the manufacturer is malem medical.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL/ BEDWETTING STORE
• MDR Report Key: 6986793
• MDR Text Key: 90542869
• Report Number: MW5073030
• Device Sequence Number: 1
• Product Code: KPN
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 8 YR