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

Device Problems Melted (1385); Smoking (1585); Failure to Shut Off (2939)

Patient Problem Burn, Thermal (2530)

Event Date 12/16/2016

Event Type  Injury  

Event Description

We have had 2 malem alarms for about a year.They were purchased from a website called the (b)(6) store.Our children will use them for a few weeks and be dry for a few months and then revert back to wetting the bed again.I like having the malems handy when this restarts and we can just wear malem again.My daughter was sleeping with the malem on (b)(6)2016 and screamed out loud.She came to tell me it was hot.The batteries were beginning to melt and the entire thing was smoking.I took it outside in the rain and left it on the concrete.I couldn't even hold onto it because it was so hot! i am so shocked that this happened when she wore it to bed.We had to go to the local hospital at night with burn marks on her neck.We had to get medical attention.We haven't gotten them wet.This alarm had been acting odd when the sensor strip would get wet, the alarm wouldn't turn off when unplugged, we would have to take the batteries out to get it to stop beeping.I am afraid to let my children use the other alarm now that this one smoked and melted.I need help with bedtime wetting, but i am afraid to use this product now.I contacted the bedwetting store the very next day and told them what happened.They said it was my error and that my daughter did something with the malem alarm.They did not provide any help to me.A few days later, my husband called them to understand what out options were since the alarms were under warranty.The owner of the place asked us if we had contacted the fda.We had no idea that this was a medical device till they brought it up.They said that if we contact fda, they cant replace or provide assistance.We asked them for options and they demanded that we send the product back to the and they would promptly reimburse us the money paid but also told us to sign a waiver and disclaimer that we would never report this to the fda or anyone else.It has now been a month and we have finally decided to write the fda about the incident.We have the alarm with us with the melted back.We have sent pictures to the (b)(6) store and in return, we have received a legal notice from them that if we take this issue further, we will likely have to face legal consequences.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6255857
• MDR Text Key: 65058528
• Report Number: MW5067232
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR