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

Model Number ULTIMATE M042

Device Problems Thermal Decomposition of Device (1071); Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Although no one was injured or hurt during the use of this alarm, its defect is necessary to spell out.This bedwetting alarm came with batteries which are required to power it on.I placed the batteries correctly and i inserted the urine sensor.Then, i started feeling the alarm getting warm.I didn't care and left only to return 30 mins later.I noticed that the alarm was smelling of burnt plastic and it would not work.Slimy liquid was spilling from the back.I had a hard time removing the batteries because the part that opens and close was bent (possibly from heat).I know for sure that this alarm has burnt or self destructed just lying on the counter-top.Not safe for anyone to use it.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8739686
• MDR Text Key: 149523953
• Report Number: MW5087649
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE M042
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR