MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS/INCONTINENCE ALARM

Device Problems No Audible Alarm (1019); Overheating of Device (1437); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 06/01/2017

Event Type  Injury  

Event Description

I purchased a malem ultimate bedwetting alarm from the (b)(6) online site to help my (b)(6) daughter stop primary nocturnal enuresis.I have been prescribing these alarms for my patients for several years and when my daughter started wetting the bed, quite naturally, i purchased one that i prescribe to my patients.The alarm did not work right from the first night we used it.The first two nights my daughter wet the bed but the alarm did not sound and in the morning she was soaking in a puddle of urine.She wanted to stop using the alarm but i insisted that she keeps trying it, assuring her that it will work.Within just a few days of use, the alarm has malfunctioned and caused severe physical harm to my daughter.The third night, my daughter screwed out in the middle of the night and threw the alarm on the floor.When i went in her room, i saw that the alarm was making a strange sound.It was as if the thing that vibrates inside the alarm was stuck.I lifted the alarm and noticed that the back side of the alarm was extremely hot.The alarm had overheated and i couldn't even hold it in my palm, it was that hot.The back of the alarm which holds the batteries got very hot when my daughter was asleep at night.It has resulted in scarring and burning on my daughters chest where the alarm was clipped.If i had not responded on time, it could have caused even more harm to her.The very next da, i brought this to the attention of the bedwetting store and they asked me to ship the alarm back to them which i did.I am extremely disappointed and frustrated that this has happened to my daughter.We are left disappointed and shocked that a small little product could do something like this.I am worried that there could be more cases of the product causing harm to children everywhere.This is an unsafe product and parents should think twice before purchasing it.It should be removed promptly till the company fixes this problem.I feel terrible for forcing her to use this product.Now she is traumatized and scared of using another product to stop her bedwetting.It's disappointing how something so small can potentially cause so much problem.A complete waste of money and i am frustrated with the quality and reliability of this product.This alarm is complete junk and a giant waste of time and money.

• Brand Name: MALEM
• Type of Device: ENURESIS/INCONTINENCE ALARM
• Manufacturer (Section D): MALEM MEDICAL; gb ; UK
• MDR Report Key: 6642820
• MDR Text Key: 77728326
• Report Number: MW5070403
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/13/2017

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2017
• 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): Hospitalization; Life Threatening
• Patient Age: 6 YR