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

Model Number M05

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

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

Event Date 04/08/2019

Event Type  Injury  

Event Description

The first two nights, the malem alarm worked just fine.It was detecting urine, but one night, it stopped detecting urine and instead made a clicking noise when the alarm was used on my son.It was evident that there is a device malfunction in there that was making this sound from the inside of the device.I am afraid to up it as it is heating up when placed on my son.I worry that it may injure him in his sleep from the heat that its producing.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING DEVICE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8515223
• MDR Text Key: 142181409
• Report Number: MW5085861
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• 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