MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number MS04C

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

I am writing from (b)(6) on the advice of health (b)(6).My wife purchased the malem alarm for our daughter.She is (b)(6) and has been bedwetting for several years.The alarm arrived and we set it up as per instructions.Four nights ago, on (b)(6), something went wrong with the alarm and it exploded at night.The heat that the alarm generated caused the product to melt.The two batteries that are in the alarm leaked out and stained my daughter's shirt.However, the hot alarm burnt her chin and neck.We had barely used the alarm for 2 hours when this happened.The alarm and batteries were brand new and it caused serious burns.Our daughter has been taken to the hospital for treatment.She was not admitted, but was discharged after treatment and f/u will be necessary.I can send pictures of her chin and neck where she has been burnt.At the advice of our doctors, we have reached out to health (b)(6) and they have also told me to complain to fda.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6721158
• MDR Text Key: 80412477
• Report Number: MW5071025
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS04C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2017
• 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