MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 09/21/2017

Event Type  Injury  

Event Description

Subject: severe burns from the malem bedwetting alarm.To whom it may concern: my (b)(6) son has suffered severe burns from the malem bedwetting alarm.We have barely used this product a handful of times.When we started using this alarm at first we realized that it used to get a little hot, but we never thought that would be a problem.On (b)(6) 2017, the alarm overheated and burnt my child.We had to rush him to the hospital where he received treatment.I have noticed that my son is now more scared and reluctant to everything.These kind of products should not be allowed here in our country.Please look into this incident soon.(b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6893746
• MDR Text Key: 87462044
• Report Number: MW5072415
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 09/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 MO