MAUDE Adverse Event Report: MALEM MALEM; ENURESIS ALARM

Model Number M04

Device Problem Leak/Splash (1354)

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

Event Date 02/08/2018

Event Type  Injury  

Event Description

My son is in deep pain after his bedwetting alarm leaked out batteries at night.It was used normally when the alarm just got short and leaked battery acid on my son's body and neck.He is in pain from this defect in the product.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7269518
• MDR Text Key: 100132190
• Report Number: MW5075216
• 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: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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
• Patient Weight: 19