MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE

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

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

Event Date 03/13/2017

Event Type  Injury  

Event Description

We bought the malem alarm so we could change diapers as soon as she wet the bed.To my surprise one day i noticed the malem battery door in her mouth.I was quick to react and take it out and fortunately there was no accidents.She was just about to gulp it down.Btw, bedwetting store has horrible customer service.Neither product nor the website has any age guidelines.I have never come across such a dangerous product in (b)(6).This product is harmful to children.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6480127
• MDR Text Key: 72631359
• Report Number: MW5069005
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• 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: 04/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR