MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2017

Event Type  Injury  

Event Description

My daughter is (b)(6).She is wetting the bed at night and we have decided to get her a bedwetting alarm.This alarm came recommended for her age.Today was the first night she used the alarm.While setting it up, she was able to remove the battery door and swallowed it in seconds.I was lucky that i was just besides her when she did that.We had to struggle to get it out of her as she had swallowed it whole.This is not for children.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6843075
• MDR Text Key: 84952433
• Report Number: MW5071937
• 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
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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
• Patient Age: 2 YR