MAUDE Adverse Event Report: MALEM MEDICAL, LTD. MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04SB

Device Problems Break (1069); Melted (1385); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 06/19/2018

Event Type  Injury  

Event Description

My son was sleeping with the bedwetting alarm and it malfunctioned at night and short circuited out.This caused the alarm to generate an immense amount of heat and the plastic housing partially melted.Additionally, the batteries leaked on his body.Although the malfunction was minor, it was significant to give him burn marks.He was taken to the hospital for immediate attention and treated for minor burns.Currently he is recovering at home.It's 2 days now and the burn marks are visible on his chest.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 7637658
• MDR Text Key: 112429585
• Report Number: MW5078030
• Device Sequence Number: 0
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 5 YR
• Patient Weight: 18