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

Model Number M04SB

Device Problem Overheating of Device (1437)

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

Event Date 04/25/2019

Event Type  Injury  

Event Description

For the last 3 weeks, i have attempted to use the malem bedwetting alarm, without any success.The first alarm which was purchased from an online store was not responding to wetness, instead, the alarm was overheating merely inserting the sensor into the alarm.The excess heat made it unusable as it could easily burn skin.I reached out to malem in (b)(4) and they exchanged the alarm with a new one.This second alarm is doing exactly the same thing.At first i thought it was a user error, but it is not.There are too many complaints of this exact same nature on this alarm.Inserting the sensor sets off a reaction which makes the alarm entirely hot and unusable.It will hurt /injure anyone who is using the device.My (b)(6) y/o son is too frightened to use a device to treat his enuresis and i am too.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD ; UK
• MDR Report Key: 8582342
• MDR Text Key: 144237993
• Report Number: MW5086377
• Device Sequence Number: 2
• 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: 05/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04SB
• Device Catalogue Number: ROYAL BLUE
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 34