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

Model Number ULTIMATE PRO

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 01/04/2020

Event Type  Injury  

Event Description

Our bedwetting alarm was purchased in a new condition from (b)(6) website.The first night alarm was operating and worked correctly, although it did not detect urine.My daughter wet herself three times at night and the alarm did not alert even once.The next morning i changed the batteries and in the night, set it up again.When i connected the sensor and set it up, my daughter said she smell burning smell from the alarm.I removed it and smelled it.It was indeed a burning smell.As i held it, i also noticed that the alarm was hotter than normal.I waited for a few mins and the smell became worse and the temperature on the alarm rose very high.At the time, for my safety and my daughter's safety, i immediately removed the batteries and disposed off the device for fear of it setting of a fire.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: CONDITIONED, ALARM, ENURESIS RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9564322
• MDR Text Key: 174292965
• Report Number: MW5092090
• 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: 01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO
• Device Catalogue Number: 1 TONE ULTIMATE ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR