MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM; ALARM CONDITIONED RESPONSE ENURSIS

Model Number M05S

Device Problem Temperature Problem (3022)

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

Event Date 03/06/2019

Event Type  malfunction  

Event Description

About two weeks ago, our bedwetting alarm abruptly malfunctioned after a week of good use.The purpose of the device is to alert on detecting urine, but this alarm isn't doing that anymore.The first week it appeared to work just fine and after that, it was unusable.It would get very hot every time the sensor would be connected inside it.This made is dangerous to operate normally.It would hurt my son easily if he would sleep with it, so we don't use it anymore.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURSIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8456310
• MDR Text Key: 140279311
• Report Number: MW5085198
• 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: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05S
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR