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

Model Number M042

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

Patient Problem Injury (2348)

Event Date 06/03/2019

Event Type  Injury  

Event Description

On the advice of my daughter's pediatrician, we purchased the malem ultimate bedwetting alarm (model m042) from the mfr directly.The alarm has been nothing more than a serious failure.It was used for 1 night during which it short circuited and overheated.The result was that my 5 y/o daughter who was asleep in her bedroom did not wake up on time and was injured by the hot alarm device.She was fast asleep and unable to remove it on time when the alarm hurt her.The alarm is not working anymore.I believe that the internal parts have burnt out.It is not operable and i also noticed that the batteries have leaked out.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8683775
• MDR Text Key: 147659817
• Report Number: MW5087223
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M042
• Device Catalogue Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR