MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Model Number M04

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problems Anxiety (2328); Choking (2464); Foreign Body In Patient (2687)

Event Date 09/14/2015

Event Type  Injury  

Event Description

I have a (b)(6) son who is bedwetting.I searched online and found this product as the website (b)(6) i purchased the malem ultimate bedwetting alarm from there can send receipt as proof of purchase.The first few nights i used it, my son seemed terrified.Then while setting it up at night, he swallowed the battery door.It was small and it just fell off when he dropped it.He swallowed it and started chocking.We had to rush him to the hospital.I hate this product.It should be taken off the market.I have never seen such a poorly made product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 5117700
• MDR Text Key: 27310597
• Report Number: MW5056709
• 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
• Report Date: 09/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2.5 YR