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

Model Number M04SB

Device Problems Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

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

Event Date 08/11/2018

Event Type  malfunction  

Event Description

This is my second bad experience with the malem bedwetting alarm.The first one was 2 weeks ago.Both alarms have the same problem.It was purchased for my (b)(6) daughter to cure her bedwetting.Both times, i purchased a new alarm from the mfr and it arrived in sealed new condition.The problem is that it gets extremely hot when i insert batteries into the alarm.The first alarm we put in batteries and let it sit and it got so hot that the batteries short circuited and leaked out of the alarm.The plastic on the outside also partially melted.Fortunately it was not in use.Thinking it was a on-off case, we returned it and bought another similar alarm, same model from the mfr.To my surprise, the same thing happened.How can this be? the device is extremely hot and there is absolutely no way any child can wear it unless they intentionally want to get burnt.The alarms are both defective and dangerous.The first one was returned back in exchange for the second one.The second one is also faulty.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7780263
• MDR Text Key: 117163617
• Report Number: MW5079082
• 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: 08/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04SB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR