MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2017

Event Type  Injury  

Event Description

I just received the malem alarm which i ordered from (b)(4).It came with batteries and i pulled out the white part to activate the alarm.This alarm is for my (b)(6) year old son who is bed wetting.I placed it on him to monitor bed wetting.A few hours later, as he was playing, the battery door came off and he picked it up and immediately swallowed it.It was a good thing that i was standing there and i noticed him put it in his mouth.He could have been seriously injured by the alarm if he had indeed swallowed the battery door.I am lucky i caught it on time.I wonder how it came off so easily and how he swallowed it.It is going to be returned back first thing tomorrow morning.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6830727
• MDR Text Key: 84105944
• Report Number: MW5071856
• 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: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Required Intervention
• Patient Age: 2 YR