MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED WETTING ALARM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

I was teaching my daughter (who is almost (b)(6) y/o) how to use the alarm.I stepped out momentarily and when i returned, i noticed that the battery door was in her mouth.I was quick to take it out or she would have swallowed it completely.If that would have happened, she would have choked.This product has small parts and is extremely unsafe for children.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6773455
• MDR Text Key: 82172025
• Report Number: MW5071433
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 08/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 MO