MAUDE Adverse Event Report: MALEM MEDICAL COMPANY MALEM BEDWETTING ALARM; ENURESIS ALARM

Model Number M04

Device Problems Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 02/12/2018

Event Type  No Answer Provided  

Event Description

We were using a different alarm before and migrated to the malem alarm.The alarm behaved erratically the very first time we used it.As soon as batteries were inserted, the alarm suddenly started getting hot and within a few mins the batteries inside the alarm part shorted out and leaked onto my daughter's body.It burnt her in the neck and chin.Although very minor, these blisters could be serious if the alarm was not removed on time.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL COMPANY
• MDR Report Key: 7292546
• MDR Text Key: 100894927
• Report Number: MW5075455
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR