MAUDE Adverse Event Report: MALEM MEDICAL LTD ULTIMATE SELECTABLE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENSURESIS

Model Number M05

Device Problems Detachment of Device or Device Component (2907); Temperature Problem (3022); Noise, Audible (3273); Device Fell (4014)

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

Event Date 03/10/2019

Event Type  Injury  

Event Description

This product lacks the features claimed.The sound is rather loud and not sure if it is safe for the user.The sensor do not attach to the underwear either.I have had a hard time getting the product to work properly and it keeps falling off.It has been used for two nights and each night, it is getting very hot at night after an hour of use.This does not seem normal, and can cause harm to my son when he is asleep.For safety reasons, i have discontinued use and contacted the manufacturer 2 times, but have not heard back either time.

• Brand Name: ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENSURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 8413975
• MDR Text Key: 138672260
• Report Number: MW5084822
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 14