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

Device Problems Leak/Splash (1354); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 08/21/2019

Event Type  Injury  

Event Description

We never thought that a small device like a bedwetting alarm can injure a sleeping child.My daughter was asleep with the device and it somehow injured her.She got burnt in her sleep and awoke in pain and blisters on her skin.The alarm was not responding and the batteries leaked inside.It was warm and i can only conclude that it somehow got hot to cause the incident.The alarm is not used or refurbished.It was purchased brand new.For a new device to injure a child is scary and just wrong.My daughter was asleep and at her age, unable to even wake up to the hot alarm and remove it.This alarm has completely scared us from using any other alarm for her treatment in the future.Injury.Fda safety report id# (b)(4).

• Brand Name: PRO BEDWETTING ALARM PRO ULTIMATE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8935490
• MDR Text Key: 156261253
• Report Number: MW5089333
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR