MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE SELECTABLE BED WETTING ALARM; ALARM, CONDITIONED

Device Problems Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 07/24/2018

Event Type  malfunction  

Event Description

The alarm is getting very hot.I did not drop it or damage it in any way.It was purchased about a month ago but i never got to using it.Tonight i was testing it with my daughter and noticed that it makes a click-click noise which never stops and the alarm is getting very hot.It is most definitely not usable the way it is because this heat can easily hurt my daughter.It only takes 15 mins and the alarm gets hot like it's ready to burn someone.

• Brand Name: MALEM ULTIMATE SELECTABLE BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7731048
• MDR Text Key: 115533453
• Report Number: MW5078664
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR