MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Premature Discharge of Battery (1057); Leak/Splash (1354); Overheating of Device (1437); Loss of Power (1475)

Patient Problem Burn(s) (1757)

Event Date 06/16/2017

Event Type  Injury  

Event Description

This alarm is complete garbage.Possibly the worst purchase i have ever made on (b)(6).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) 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 him, who sleeps like a log.The alarm has a habit of going off erratically for no reason.No matter how many times you clean and dry the sensor, even leaving it open overnight to let it dry and shaking it vigorously will not fix the problem.Setting up the alarm isn't easy either.The minute you attach it to the underwear, it starts to go off like something is wet.It even goes off when placed on the center table with nothing attached to it.After struggling for 20-30 minutes each night, we would finally get it to stop beeping and she could go to bed.The serious problem is that the alarm overheats.As soon as the sensor is 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 his bedtime for added safety.One night, the back of the alarm got so hot that the batteries leaked out.I was even unable to hold it in my hands.We had to get him burn ointment to address the problem in the middle of the night.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 son.We were fortunate enough to step in the moment our son let out a scream.He suffered burns from the back of the alarm and i believe that this could have been worse if we had not stepped in on time.This product was returned back to (b)(6).Use at your own risk.This is a horrible product.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; cn
• MDR Report Key: 6662947
• MDR Text Key: 78361397
• Report Number: MW5070576
• 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: 06/21/2017

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: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2017
• 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: 8 YR
• Patient Weight: 38