MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Model Number M4S

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 07/13/2017

Event Type  Injury  

Event Description

Batteries leaked out of the bedwetting alarm.It was in use for only 2.5 hours and in the late hours of night, the alarm burnt my daughter's neck and the batteries leaked out of her neck.If she had any cut near that region, it would have been dangerous.My daughter is only (b)(6) and this has our family scared and worried now.We are also deeply disturbed that the alarm which was supposed to help cure her bedwetting actually burnt her in the neck.Better she wet the bed than get burnt in the neck.Very dangerous product.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6756414
• MDR Text Key: 81579098
• Report Number: MW5071296
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M4S
• 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: 3 YR