MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BEDWETTING ALARM

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Fumes or Vapors (2529)

Patient Problem Burn, Thermal (2530)

Event Date 08/03/2017

Event Type  Injury  

Event Description

I ordered the malem ultimate selectable bedwetting alarm from (b)(6).I received the alarm and used the product just once as we were traveling.The very first night of use, this alarm has malfunctioned and caused serious pain and suffering to my son and our family.This alarm was set up as per instructions and user manual.It was simple and i put my son to bed.My son is only (b)(6) an hour later, there were repeated screams from my son's room.My wife and i found him breathing heavily and frantically trying to pull off the alarm from his neck.There were fumes from the alarm and batteries had leaked out of this product onto his clothing and chest.We removed the alarm and found that the alarm has malfunctioned on first use.The alarm overheated so much that the plastic battery door that contains the batteries has melted and batteries have leaked out on my son's body.The heat of the melting batteries and melting plastic burnt him very badly.He has suffered burns on his neck, chest and chin area.Also in removing the alarm from his neck, his fingers are burnt.I would like to send photos of his burns, so you can see firsthand what has happened to him.We are traumatized from this experience."how can a product which is intended for children malfunction like this." my son was taken to the hospital and was treated for this condition.The burns have now become blisters and he is in tremendous pain.All for my fault of his.We feel helpless in this situation.

• Brand Name: MALEM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6800092
• MDR Text Key: 82988944
• Report Number: MW5071602
• 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: Attorney
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 5 YR