MAUDE Adverse Event Report: MALEM MEDICAL LTD. BEDWETTING ULTIMATE ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Lot Number M043

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

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/07/2019

Event Type  Injury  

Event Description

My son has been hurt using his alarm.The alarm was attached on his body as instructed, but 30 mins into the night when he was asleep, the alarm got extremely hot and a sharp stinging sensation woke him up.The upper portion of the alarm was hot and it hurt him.He felt like the alarm was on fire and it stung him badly.I noticed that the alarm has battery leaks on the outside from high heat.We are scared to continue to use an alarm treatment on him going forward.Just too dangerous.He's older and was able to wake up.If he were younger, this would have been a disaster for us as he would surely get burnt.High heat on his skin.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8712262
• MDR Text Key: 148546098
• Report Number: MW5087446
• 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: 06/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: M043
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR