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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/05/2019

Event Type  Injury  

Event Description

My son is a deep sleeper and is wetting the bed nightly.I was using the wet call bedwetting system, but it was not working even after 3 months, so after reading reviews and seeing many ads, i bought malem ultimate for him.This has been a dangerous experience for my son.He was sleeping in bed and this was the first night he was sleeping with this new alarm.He was screaming at night when i heard him and went to his room.There was burning plastic smell and he was crying.The alarm was hot and too hard to remove from him.He was injured at neck area and skin was red from burns.The alarm isn't working.It likely burnt out and self destructed.My son is (b)(6) and didn't deserve to be burnt in his sleep.Hes still scared and worried even looking at this alarm.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8696480
• MDR Text Key: 148073772
• Report Number: MW5087329
• 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: 06/10/2019

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 Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR