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

Model Number M04S

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Burn(s) (1757)

Event Date 08/01/2017

Event Type  Injury  

Event Description

At the advice of pediatrician, purchased a malem bedwetting alarm from (b)(4).The alarm worked fine the first night, but on the second day, the alarm acted strange.The back casing of the alarm overheated and the batteries leaked out onto my son's skin.The alarm has burnt my son's neck and he had to be taken to the clinic for first aid treatment.The battery leak and melting of the back cover have left us in a state of shock.This alarm is dangerous for children.This complaint is being made at the advice of the clinic.The product has been returned to (b)(4).

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6793855
• MDR Text Key: 82770264
• Report Number: MW5071554
• 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: 08/12/2017

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
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 3 YR
• Patient Weight: 17