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

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

Patient Problem Burning Sensation (2146)

Event Date 12/30/2019

Event Type  Injury  

Event Description

The alarm did not work as described for the first night.The reset button jammed (got stuck in the casing and would not pop back out).The device then got too hot to operate and i had to remove batteries.I had to get out of the reset button with the use of a small screwdriver to dislodge.Now, when i am trying to use, the alarm, it is heating up.My son wears it and says that he is burning with it as it is hot.As such, we cannot use the device, after one night i would not expect this kind of mfg problem and unreliability in a medical device.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9543512
• MDR Text Key: 173742646
• Report Number: MW5092014
• 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: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Device Catalogue Number: SINGLE TONE ALARM
• 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: 5 YR