MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED WETTING ALARM

Device Problems Premature Discharge of Battery (1057); Overheating of Device (1437); Product Quality Problem (1506); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Pain (1994); Scar Tissue (2060); Burn, Thermal (2530)

Event Date 03/05/2017

Event Type  Injury  

Event Description

My (b)(6) daughter was bedwetting so i researched online and purchased a malem bedwetting alarm on (b)(6).This alarm is completely garbage.It overheats periodically and sucks batteries in a few days.It won't wake up your child even after several nights of use.My (b)(6) daughter did not wake up to the alarm no matter how we positioned it.I slept in the same room and i could barely hear the alarm let alone her, who sleeps like a log.One night, i set up the product and placed it on my daughter as she was going to bed.As soon as the sensor was inserted, the alarm makes a constant hissing sound and then starts heating up.At first, we thought that getting a little hot is normal and we would wrap and place a piece of tissue in the area between the alarm and back and the t-shirt before her bedtime for added safety.Three hours later, she cried out in pain.The product had malfunctioned and the batteries had leaked out.The back casing was so hot that it burnt a hole in my daughter's t-shirt and scarred her neck.I was even unable to hold it in my hands.We had to get her burn ointment to address the problem in the middle of the night.This is horrible.On close observation, i noticed that the product is made of cheap quality and its risky for a child to be wearing it and sleeping at night.I am fortunate that we did not wait any longer or this could have been serious and even caused permanent harm to my daughter.Please look into this matter as what happened to my daughter today and could happen to someone else tomorrow and the day after.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6394594
• MDR Text Key: 69748776
• Report Number: MW5068362
• Device Sequence Number: 1
• Product Code: KPN
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHILDREN'S VITAMINS SUPPLEMENTS; OTC MEDS: CHILDREN'S PROBIOTICS AND; RX MEDS: NEBULIZER
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR