MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM

Model Number ULTIMATE SELECTABLE ALARM

Device Problems No Audible Alarm (1019); Melted (1385); Overheating of Device (1437); Device Inoperable (1663); Temperature Problem (3022); Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840); Scarring (2061); Depression (2361)

Event Date 05/25/2017

Event Type  Injury  

Event Description

I have serious concerns with the safety and functionality of the malem alarm i was holding back from reporting it till the alarm burnt my son.I am completely frustrated with the purchase.It is a dangerous product and it does not work.The malem alarm was purchased for my (b)(6) son who is a chronic bedwetter with high hopes of working.The alarm comes with a useless user manual.It is a giant book which is designed for all malem alarms so it is confusing to figure out which pages are for your specific alarm.You really have to struggle with understanding the user manual.In addition, they have tons of advertisements thrown into the box to buy add'l products from the website (bedwettingstore.Com).I set up the first night and slept in the same room, on the same bed as my son and i am a light sleeper.The first night, the alarm didn't even wake me up let alone wake him up.Same thing happened the second night.The sound is very faint and under the blankets, barely audible.The third night in the middle of the night, my son screamed out.The alarm was making a strange clicking sound as if something was stuck inside the alarm.I pulled it off his t-shirt and noticed that the back of the alarm had heated to a point where the plastic backing had melted.It was so hot i couldn't even touch it.My son's neck was red.I pulled out the alarm and threw it to the floor.I even burnt my finger tips in the process.This is a useless and dangerous product.Now i have a son who is disappointed and depressed that he will never stop bedwetting thanks to the malem alarm, let alone the scarring on his neck.We would have been safer and better off without purchasing this garbage.The following day my husband contacted the website from which we purchased the alarm and we returned the alarm back to them.They have not even refunded us as yet and every time we call, they refuse to answer the phone.I worry that if i had woken up later or my son had not cried out on time, it would have been near fatal.God alone knows how dangerous this alarm is.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6636824
• MDR Text Key: 77438357
• Report Number: MW5070380
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE SELECTABLE ALARM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 6 YR