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

Model Number PRO ALARM

Device Problems Overheating of Device (1437); Smoking (1585); Noise, Audible (3273)

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

Event Date 12/10/2019

Event Type  Injury  

Event Description

This is a new bedwetting alarm but something is wrong with it.The instructions say to insert batteries and then to insert sensor and place on child.However when i am inserting sensor, the alarm is tickling (making sound like vibrating watch).I removed sensor and it stops.But if sensor is connected and batteries are changed.Same thing; the alarm keeps clicking.I was not sure that it was normal so i waited.Then i saw some smoke coming out from the top of the alarm and it was so hot.My husband wore gloves and removed the batteries, he said it was smelling and too hot for safe use.Fda safety report is # (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9467083
• MDR Text Key: 171629339
• Report Number: MW5091653
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PRO ALARM
• Device Catalogue Number: ULTIMATE MODEL
• 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): Required Intervention
• Patient Age: 6 YR