MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M04S

Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problems Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 10/02/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm which was being used by my son has malfunctioned.The alarm overheated and the batteries leaked out on his clothing and body.This has caused several burns on his skin and allergic reaction from the battery leak.I administered first aid but the skin has visible blisters and is peeling with dark red patches.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham ; UK
• MDR Report Key: 6950912
• MDR Text Key: 89471962
• Report Number: MW5072750
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M04S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 23