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

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 11/20/2019

Event Type  Injury  

Event Description

On advice of pediatrician, purchased a bedwetting alarm to be used in conjunction with ddavp.Alarm was non-functional and overheating on battery insertion.Called company and they promptly replaced the alarm with a new one unfortunately new alarm is operating the same way.Insert batteries and set up device with sensor and takes no more than 20 mins to go from room temperature to over 150 f.Too dangerous to use.Worried that keeping sensor and batteries inserted will cause temperature to go even higher and cause device to explode.Has been returned to mfr.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: 9416774
• MDR Text Key: 169511517
• Report Number: MW5091441
• 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: 12/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Required Intervention
• Patient Age: 6 YR