MAUDE Adverse Event Report: MALEM MEDICAL & BEDWETTING STORE MALEM BEDWETTING ALARM

Device Problem Melted (1385)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 10/05/2017

Event Type  Injury  

Event Description

I bought the malem bedwetting alarm from the bedwetting store for my (b)(6) son.On day 3, the alarm overheated which resulted in the battery door melting and burning my son's neck.My son was in severe pain and we had rush him to our family physician.Even after 20 days he is still in pain."what kind of nonsensical product is that." "why is this product being allowed here in the united states." i have noticed that many other parents have reported a similar incident online, then "why has this product not been recalled yet.".

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL & BEDWETTING STORE
• MDR Report Key: 6986478
• MDR Text Key: 90637607
• Report Number: MW5073003
• 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: 10/26/2017

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR