MAUDE Adverse Event Report: MALEM MEDICAL BED WETTING ALARM; ENURESIS ALARM

Model Number M04

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  Injury  

Event Description

Ever since we have purchased the malem bed wetting alarm, we have had issues with it.The first time we tried the alarm was 3 nights ago.Upon inserting batteries into the alarm, the alarm portion started vibrating and getting warm to touch.We did not use it that night and changed batteries to use the following night.The same thing happened.We again had tried to use the alarm with a fresh set of batteries, but each time we did that, the same thing happened.The product started getting warm and then last night, it got very hot so we stopped using the alarm all together.The alarm got hot to where we could no longer touch it.This could easily have burnt someone.It is possible that we got a defective product which is malfunctioning, but we will not be using it on our daughter.

• Brand Name: BED WETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7295736
• MDR Text Key: 101011419
• Report Number: MW5075482
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 24