MAUDE Adverse Event Report: MALEM MALEM ALARM; BED WETTING ALARM

Model Number M04

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

Patient Problem Choking (2464)

Event Date 10/10/2015

Event Type  Injury  

Event Description

Purchased a product from (b)(4) it is called the malem bedwetting alarm, 1 tone with vibration.Horrible product.It is advertized as a product for children ages 2 and older.My son is not even 3 and he used the product and swallowed the battery door.He choked.Worst product ever made.We called 911 and had to induce vomiting.

• Brand Name: MALEM ALARM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 5161666
• MDR Text Key: 28832387
• Report Number: MW5057177
• Device Sequence Number: 1
• Product Code: KPN
• 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: 10/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 2 YR