MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number SINGLE TONE PRO

Device Problems Vibration (1674); Defective Component (2292); Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 02/14/2019

Event Type  malfunction  

Event Description

Received malem bedwetting alarm yesterday and it doesn¿t appear to be safe to use.On placing batteries in the slots, the alarm starts making mini vibrations.It takes about 15 minutes and you can feel it hot at the back.I am worried that if i use this on my daughter, it may actually hurt her.Tested multiple times, same result.Something is rattling inside the product too.Clearly a dead on arrival or defective device.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8362180
• MDR Text Key: 137122933
• Report Number: MW5084206
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SINGLE TONE PRO
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR