MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BEDWETTING ALARM

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Material Deformation (2976)

Patient Problem Burn(s) (1757)

Event Date 06/22/2017

Event Type  Injury  

Event Description

The malem alarm was prescribed for my (b)(6) daughter by dr (b)(6).We were given a brochure and we purchased the alarm from an online website.The alarm came with partial instructions of use.Although the user manual was generic we got it right and saw online videos.We removed the battery tabs and started the alarm that night.The sensor was clipped outside the underwear and the alarm was placed on the t-shirt.After set up that night, i set my daughter to sleep and i slept with her in case.I needed to wake her up.At about 3:30am that morning.I smelt something burning.It smelt like plastic and i turned on the lights.The malem alarm was smoking.It wasn't a lot, but there was smoke coming out of the alarm.This alarm was on my daughter and she was fast asleep.I immediately removed the alarm and placed it on the side table.It was extremely hot.The batteries had leaked out and there was gray matter on the bed and her clothes.My daughter was only burnt from the heat of the alarm, but batteries could be toxic i think.The alarm sat there on the table and within a few minutes, the back started melting and an hour later, it was deformed.The back casing had melted from the excessive heat and if my daughter had that on her at the time, it would be extremely dangerous.We did notice some marks on her neck and areas where the alarm was placed.Immediately we resorted to first aid and the next morning took her to dr (b)(6).For a child this young, the product could have been deadly and i am happy that i was in the same bed with her or she probably would have been in the hospital with burn marks on her body.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 6713494
• MDR Text Key: 80156588
• Report Number: MW5070973
• Device Sequence Number: 1
• 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: 07/12/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22