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

Model Number ULTIMATE ALARM

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Emotional Changes (1831); Scarring (2061)

Event Date 11/07/2019

Event Type  Injury  

Event Description

Bedwetting alarm device short circuit at night and batteries leaked out.This caused the system to overheat and injured my son.He was asleep and into 2 hours of his sleep.Very dangerous product.Resulted in night scare and worries.Son is more afraid not to use any bedwetting system.We are also scared.The alarm has left scar on his body.Very disappointed.Burns.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9315654
• MDR Text Key: 166335852
• Report Number: MW5091005
• 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: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2019
• Device Model Number: ULTIMATE ALARM
• Device Catalogue 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; Required Intervention
• Patient Age: 5 YR