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

Model Number M04S

Device Problems Circuit Failure (1089); Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2018

Event Type  Injury  

Event Description

The complaint is for the malem enuresis alarm.A brand new alarm was turned on when batteries were installed.Within a few minutes (10 mins or so), the device started warming up and 30 mins later, the device short circuited and leaked out batteries.The back plastic casing of the alarm has bent inward from the heat and deformed.This could have been extremely dangerous for a young child who would have worn it during sleep.Fortunately the child was not wearing it at the time.The battery leak spread on the countertop.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7518012
• MDR Text Key: 108499683
• Report Number: MW5077225
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 17