MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Model Number M04S

Device Problem Material Separation (1562)

Patient Problem Choking (2464)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Our (b)(6) dropped the bedwetting alarm on the floor and the battery door snapped out.Child swallowed the battery door and it could have been fatal as she started choking on it.This is a problem as the battery door which has no safety markings for child use.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6983225
• MDR Text Key: 90631812
• Report Number: MW5072984
• 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: 10/25/2017

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
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR