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

Model Number M048TEC

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

Patient Problems Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 04/17/2018

Event Type  Injury  

Event Description

My son was burnt on the neck when his malem alarm short circuited and leaked batteries on his body.The alarm was extremely hot and that was likely caused by the batteries short circuiting inside the alarm portion.After that, extreme heat, the batteries inside the alarm leaked out on to his skin and spread over his neck area where i had attached the alarm portion.It caused skin irritation on his neck which has resulted in small burn marks.I have taken my son to the er for treatment and his treatment is still ongoing even after one week.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7457481
• MDR Text Key: 106582146
• Report Number: MW5076672
• 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: 04/23/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR