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

Model Number BLUE SINGLE TONE

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  Injury  

Event Description

Unfortunately the alarm didn't work, as soon as we placed the batteries in and got ready to test it, it became extremely hot and smelled like burned plastic.I took the batteries out and replaced them with new ones.Every time same thing happened.I have reached out to the seller where i purchased it but i am not getting any answers, so i sent it back for a refund.It's kind of scary thinking that it could happen in the middle of the night and burn the child.Note: it's really / very hot.Too hot to even hold in hands and it stinks really bad.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8817562
• MDR Text Key: 152031593
• Report Number: MW5088289
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BLUE SINGLE TONE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR