MAUDE Adverse Event Report: ENURESIS ASSOCIATES MALEM BEDWETTING ALARM

Device Problem Insufficient Information (3190)

Patient Problem Choking (2464)

Event Date 05/06/2016

Event Type  Injury  

Event Description

I purchased the malem bedwetting alarm for my (b)(6) at the advice of the company's customer support team.I still have the chat.Product arrived yesterday.The first night, i opened the alarm to insert batteries.During the time i was inserting the battery compartment door, my son swallowed the battery door and started to choke.Had to rush him to er.Terrible product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): ENURESIS ASSOCIATES
• MDR Report Key: 5646250
• MDR Text Key: 44900176
• Report Number: MW5062175
• Device Sequence Number: 1
• Product Code: KPN
• 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: 05/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 15