MAUDE Adverse Event Report: MALEM MEDICAL COMPANY MALEM ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Product Quality Problem (1506)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 12/29/2017

Event Type  Injury  

Event Description

My daughter is (b)(6) and about to turn (b)(6) in (b)(6) 2018.I purchased the malem bedwetting alarm from the internet so i could stop her from bedwetting at night.She was playing with the alarm and the battery door popped open and she swallowed it.She choked on the door and i had to induce vomiting to get it out of her neck.The part is so small and it fell off very easily just by shaking the same.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL COMPANY
• MDR Report Key: 7159782
• MDR Text Key: 96331000
• Report Number: MW5074334
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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): Life Threatening; Required Intervention
• Patient Age: 2 YR