MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM PRO; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number PRO ALARM

Device Problems Malposition of Device (2616); Material Twisted/Bent (2981)

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

Event Date 07/16/2019

Event Type  Injury  

Event Description

One month of use and my son still doesn't wake up / hear / feel the alarm, but more importantly, and why i would encourage any one to immediately stop using this, there is no way to shorten the wire connecting the sensor and the alarm unit.When i went in to wake up my ((b)(6) y/o) son this morning, the cord was wrapped around his neck.Do not buy, do not use.Completely unsafe.I contacted malem but they never replied to my many emails and phone calls.Fda safety report id# (b)(4).

• Brand Name: MALEM PRO
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8821990
• MDR Text Key: 152160778
• Report Number: MW5088315
• 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: 07/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PRO ALARM
• Was Device Available for Evaluation?: No
• 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