MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL; BEDWETTING ALARM

Model Number M04S

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Material Deformation (2976)

Patient Problem Burn(s) (1757)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

On (b)(6) at 3:30am, my son complained that his bed-wetting alarm was very hot.I removed it from his shirt and within a few minutes, the alarm started to smoke and the back plastic housing deformed from the heat and the battery door melted.On inspection, i noticed that my son had burn marks on neck and chest.The er doctor administered first aid and we were let go after treatment.We were called back in for f/u treatment which lasted 2 weeks.My son still has burn marks from use of the alarm on his neck and chest.The alarm has been given to the hospital and the doctor said he would analyze and contact the fda as well.

• Brand Name: MALEM MEDICAL
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 6721162
• MDR Text Key: 80397828
• Report Number: MW5071026
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2017
• 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 Age: 8 YR
• Patient Weight: 27