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

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 06/05/2019

Event Type  Injury  

Event Description

The malem bedwetting alarm overheated and hurt my child.It was in such bad state that the batteries leaked as well.The burns were so bad that we had to apply ointment twice a day for a few weeks to ease his pain.This is unacceptable.I reached out to the mfr, however their customer service is extremely impolite and discourteous.You should have your team look into it and ban this product for sale in the us.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8758331
• MDR Text Key: 150145717
• Report Number: MW5087811
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR