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

Model Number M042

Device Problem Break (1069)

Patient Problem Burn, Thermal (2530)

Event Date 11/19/2019

Event Type  Injury  

Event Description

Don't know how it happened or what cause the incident, but my son was asleep and woke up with a burn on his skin in the morning.The alarm was fried and non responsive.The alarm injured my son even as he was just asleep in bed.It was a new alarm and purchased on the recommendation of the dr.I took him to the dr in the morning and was advised to stop using the alarm and report this incident to the fda.Alarm has a defect.It injured sleeping child at night.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9368772
• MDR Text Key: 167809506
• Report Number: MW5091257
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• 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