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

Model Number M04

Device Problems Device Alarm System (1012); Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

Second night used my son wet the bed and the alarm won't stop beeping and getting super hot.He was scared and came running saying that the alarm was burning him.I had to pull batteries out, wait an hour and put them back in, and it still beeps and gets hot.I don't believe it will work for him.I think this is a dangerous product the way it is getting hot.It will burn skin on contact for more than a min.Very scared to try this on any other system.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8856691
• MDR Text Key: 153842404
• Report Number: MW5088682
• Device Sequence Number: 0
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR