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

Model Number ULTIMATE SELECTABLE ALARM

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

Something wrong with the device.I saw online videos and set it up as directed.Put in batteries that came with it and then put the sensor inside.Alarm started making noise like something was stuck.Removed sensor and noise went away.Inserted it in and noise came back.The noise was not loud, but like a tapping noise.I started getting ready to put it on my daughter when she said that she thought the alarm was hot.I checked and it was hot.I removed it from her and held it in my hand.It kept getting hotter and hotter till i was unable to hold it.I removed the sensor and batteries, and it cooled down.I then changed the batteries also and repeated the process.The alarm got hot again.Something is wrong.Item is either defective or just damaged.Either way, it is not possible to use on anyone because it's way too hot to operate.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: 9504341
• MDR Text Key: 172591428
• Report Number: MW5091785
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE SELECTABLE ALARM
• Device Catalogue Number: ROYAL 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: 5 YR