MAUDE Adverse Event Report: MALEM MEDICAL LIMITED BEDWETTING ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number MALEM

Device Problem Overheating of Device (1437)

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

Event Date 03/20/2020

Event Type  Injury  

Event Description

This is the second time we have had a problem with this particular brand of bedwetting alarm.We purchased a malem from (b)(6) and the moment we inserted batteries, the device got super hot.I called malem and they told me to return the alarm for a new one.After doing that, the new alarm which was a replacement for the old one is also doing the same thing.Just gets hot when batteries are inserted rendering the device completely useless and dangerous.The outside temperature easily exceeds what is normal.Too hot to operate.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LIMITED
• MDR Report Key: 9877376
• MDR Text Key: 185049254
• Report Number: MW5093907
• 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: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MALEM
• 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