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

Model Number MO48TEC

Device Problems Device Alarm System (1012); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

My son got burnt on the neck area when he was sleeping at night with the malem alarm.The batteries inside the alarm shorted out at night when he was sleeping and burnt him.I gave him a cold water rinse, but it caused blisters.The alarm has a problem where it got very hot at night.This alarm was purchased new from (b)(6).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7493892
• MDR Text Key: 107701469
• Report Number: MW5077028
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO48TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR