MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Model Number M04

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

Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530)

Event Date 12/24/2017

Event Type  Injury  

Event Description

Batteries in the bedwetting alarm leaked out when the alarm short circuited under normal use the first day.Switched from another brand (nytone) to the current one (malem).The malem alarm got very hot within minutes of inserting the batteries and as time went by, kept getting warmer and warmer till it got to a point where it was extremely hot and the batteries shorted out.Battery leaked on to child's body and caused severe burns and bruises.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7154318
• MDR Text Key: 96127792
• Report Number: MW5074271
• 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: Other
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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): Other
• Patient Age: 6 YR
• Patient Weight: 25