MAUDE Adverse Event Report: MALEM MALEM ULTIMATE BEDWETTING ALARM

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Scarring (2061)

Event Date 07/09/2017

Event Type  Injury  

Event Description

Was prescribed a bedwetting alarm for daughter.Doctor said a combination of ddavp and alarm treatment would work well.The medications started and the alarm worked fine for 2 days.The 3rd night, the alarm got super hot and the batteries leaked out on my daughter's neck.There were minor scars from hot plastic but we were quick to react.Nothing major, just a minor scar on the neck.But worth reporting because of battery leak and scars.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6728174
• MDR Text Key: 80640170
• Report Number: MW5071093
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR