MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ULTIMATE RECORDABLE ALARM; ENURESIS ALARM

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 06/14/2017

Event Type  Injury  

Event Description

Unfortunately, i ended up buying a wrong and unsafe product for my (b)(6)daughter.The malem alarm got very hot at night during regular use.The batteries in the alarm seem to have leaked out and the gray matter has spilled all over her neck and chest.It was very hot and it burned her clothing.We had to take off the alarm and she was taken to the doctor in the morning.How can the children's products be so unreliable and dangerous?.

• Brand Name: MALEM ULTIMATE RECORDABLE ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6653067
• MDR Text Key: 78030370
• Report Number: MW5070488
• Device Sequence Number: 1
• Product Code: KPN
• 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: 06/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 19