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

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/04/2018

Event Type  Injury  

Event Description

My son was using his bedwetting alarm and the alarm got so hot that it burnt my son.My son also got burnt by the hot battery acid that leaked from the alarm when it exploded.This is a very dangerous product.I had to put lotion on him to prevent further burning.It would have been disastrous if i had not intervened.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7250917
• MDR Text Key: 99547228
• Report Number: MW5075110
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 4 YR