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

Model Number M042

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

I am reporting an incident in which my son was injured.He is a chronic bedwetter and on the advice of his dr, we used an alarm to stop his bedwetting.This did not help.He was asleep and came into the room complaining that there was bad smell from the alarm and then he was burnt.I thought it is not possible and checked on him.He has a red mark about the size of a quarter on his skin near his neck.I asked him where the alarm was and he said he left it in the bedroom.I checked the alarm and it was really very very hot.I was worried to even touch it.I pushed it out of the bed onto the floor and let it sit there.Checked again after 10 mins and it was cooler and about 20 mins later, was cool again, but the device burnt out itself.Was useless.There is a serious defect in this device.My son is shaken up.His burns are minor and he will recover, but the trauma caused has shaken him and us.We won't be using this or any device like this again.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8965301
• MDR Text Key: 156867239
• Report Number: MW5089571
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: BEDWETTING ALARM
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR