MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Lot Number NONE

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/02/2018

Event Type  Injury  

Event Description

So disappointed.My son who is (b)(6) and has had bedwetting problem and we tried the malem bedwetting alarm that worked good for three days and on the 4th all of a sudden, i could hear my son yelling and called me to his room and told me to touch the alarm.It was like boiling hot water.He had a visible red patch on his neck.I had to give him first aid treatment.I never expected to encounter such dangerous products for children in the market.This product should be removed from the consumer market immediately.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7984249
• MDR Text Key: 124500438
• Report Number: MW5080684
• 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: 10/17/2018

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: Lay User/Patient
• Device Lot Number: NONE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR