MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/02/2017

Event Type  Injury  

Event Description

My complaint about the malem bedwetting alarm should be taken very seriously as it has harmed my grand daughter so much that she had to be hospitalized for a night to be cured.The alarm is very unstable and dangerous.It got hot within 2 hours of use and burnt my grand daughter's neck.This bedwetting alarm should be removed from the us market.I bought this alarm from the (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6968201
• MDR Text Key: 90040436
• Report Number: MW5072867
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR