MAUDE Adverse Event Report: MALEM MEDICAL BEDWETTING ALARM

Model Number M05

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Electrical Shorting (2926); Temperature Problem (3022)

Patient Problems Erythema (1840); Peeling (1999); Rash (2033); Burn, Thermal (2530)

Event Date 01/23/2018

Event Type  Injury  

Event Description

Our (b)(6) daughter had been burnt from the use of the malem alarm.It was ordered new and arrived from an online website.The alarm was set up exactly as per the instructions and placed on her.In 45 mins, the alarm got to a pont where it was so hot that it burnt a hole in my daughter's clothing, to make matters worse, the device short circuited and the batteries exploded within the device and leaked all over my daughter's neck and hands.She has been badly burnt from the battery and melting plastic cover.We had to get her first aid treatment for the burns.She is recovering even after a week and not getting any better.The red scars are peeling off and her skin appears to have severe rash.

• Brand Name: BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7230507
• MDR Text Key: 98747272
• Report Number: MW5074966
• 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
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• 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): Required Intervention
• Patient Age: 4 YR