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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 05/02/2019

Event Type  Injury  

Event Description

Daughter has got burns on skin and rash from the use of her alarm.Alarm is defective.Alarm is very hot when i removed it from her and it had burnt her.It was hot like a table iron.The alarm is not working now.I have taken my daughter to the dr's office and they said this is very strange and such a small device should not do this.It is not something we did.It is something that happened by the alarm which was new and used as instructed.It is 2 days and daughter is still in pain from the burns and complete shock of using the alarm.Burns on neck.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8591483
• MDR Text Key: 144661441
• Report Number: MW5086465
• 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: 05/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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: 6 YR