MAUDE Adverse Event Report: MALEM UNIVERSAL ALARMS; BEDWETTING ALARM

Model Number ULTIMATE 1

Device Problem Detachment Of Device Component (1104)

Patient Problem Choking (2464)

Event Date 07/01/2015

Event Type  Injury  

Event Description

A friend of mine and fellow parent came to me after her child was saved from choking on a detachable battery cover of a bedwetting alarm.The parent came to me as she knows of my 30 years of regulatory compliance experience.She did so in the hope that my insights and lab contacts might assist in determining if this is a safe product and that maybe, her incident was a fluke.So i did a deep dive and found that not only is it not a safe product mechanically (swallowable parts and pinch points from the safety pin) but chemically (failing lead, bromine, mercury and phthalates levels) but also from the fda age guidance and lot # requirements.I have compiled these findings and non-conformances in the attached report in the hope we can keep children from getting hurt or worse.

• Brand Name: UNIVERSAL ALARMS
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• Manufacturer Contact: malem ; 10 willow holt; nottingham NG14 -7EJ ; UK NG14 7EJ
• MDR Report Key: 5060355
• MDR Text Key: 25224739
• Report Number: MW5055995
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 09/02/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE 1
• Device Catalogue Number: NOT LISTED BY THE MFGR
• Device Lot Number: NONE LISTED BY THE MFGR
• Other Device ID Number: NO UDI LISTED ON THE DEVICE NO
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 22