MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED WETTING ALARM

Model Number M05S

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994); Swelling (2091)

Event Date 08/03/2017

Event Type  Injury  

Event Description

I purchased a malem ultimate selectable bedwetting alarm with vibration - camouflage from (b)(6) on (b)(6) 2017.We have only used the alarm one night which was last night.I put it on my son at 9pm at night and went to bed.An hour and a half later, i heard a loud scream from my son's room and crying.My husband and i went to the room and found our son crying in pain.The malem alarm had malfunctioned and overheated.The battery door which houses batteries in the alarm unit had melted from excessive heat and the batteries had leaked out of the alarm unit and spilled onto his neck and chin area.Battery spills can be very toxic.We immediately removed the alarm and noticed big red patches on his neck.My wife and i rinsed the area with lukewarm water but it was not enough.Within a few minutes, his neck and face started to swell from the adverse effect of the batteries that spilled onto his neck.We had to rush him to the er in the middle of the night and he was being admitted for burns and adverse effects to the battery spill.My son was not discharged the same day and he had to spend a night in observation.This alarm is very dangerous.I am not angry, but also upset, disappointed and shocked that this alarm could do this to my son.My son got admitted to the er for no fault of his and had to stay there the whole night."why can't this company inspect products before they sell them." today it is my son, tomorrow could be other children.The doctors say that his burn marks will remain for several months and the swelling will be there for weeks.All i know is that if i had not reached on time, this alarm could have been fatal.The alarm melted from heat.It is a safety hazard and extremely dangerous for children.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6776669
• MDR Text Key: 82370025
• Report Number: MW5071440
• 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: 08/07/2017

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
• Device Model Number: M05S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 7 YR