MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M04S

Device Problems Circuit Failure (1089); Leak/Splash (1354); Battery Problem (2885)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 03/21/2018

Event Type  Injury  

Event Description

It was 3am in the morning and my daughter's malem bedwetting alarm short circuited and burnt her in the chest.The batteries leaked from the alarm and on to her clothes.She was in extreme pain from the burns from the alarm.How can a small alarm like this burn a child.It is confusing.Was using batteries supplied with the original alarm and using exactly as instructed in the user manual.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 7365068
• MDR Text Key: 103347443
• Report Number: MW5075982
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• 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): Required Intervention
• Patient Age: 4 YR