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

Model Number M

Device Problems Vibration (1674); Temperature Problem (3022)

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

Event Date 03/30/2019

Event Type  Injury  

Event Description

The malem bed wetting alarm is not operating correctly.It is getting very hot when the sensor is clamped down on the underwear.When left by itself, the alarm unit is quiet and at room temperature, but when the sensor is inserted, the alarm starts to gently vibrate and get hot.This is making us doubt the safety of the alarm as the temperature on the outside of the alarm is constantly rising and very hot.Within 35 mins, it was too hot to hold in the hand.Had to drop it on the floor for the batteries to come out and that is how it cooled down.Fda safety report id# (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8482729
• MDR Text Key: 141008478
• Report Number: MW5085562
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M
• Device Catalogue Number: 04S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR