MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWTTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Overheating of Device (1437)

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

Event Date 12/18/2017

Event Type  Injury  

Event Description

I bought the malem bedwetting alarm from the (b)(6) store.It did get hot a couple of times during the first week, but we thought that's how it is supposed to be."how would i know that it would burn my son." yesterday we had to rush him to the dr for treatment.The alarm was scorching hot and my son yelled out in pain at night.There is some serious fault with this product.It overheats for no reason at all.My son will have to miss school the next couple of days.This is totally unacceptable.I request the fda to take necessary action.

• Brand Name: MALEM BEDWTTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7138405
• MDR Text Key: 95605844
• Report Number: MW5074146
• 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: 12/19/2017

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: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR