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

Model Number M042

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2019

Event Type  Injury  

Event Description

We have not yet used the bedwetting alarm because we are scared it may cause serious injuries.I purchased this alarm new directly from the mfr's website and it was delivered to me.It came with batteries.However, when the batteries are inserted, things look fine, but setup requires me to insert the sensor.Once the sensor is inserted, within mins, there is burning smell coming from and it's getting hot.If sensor is removed, the alarm is back to room temperature and no smell.Batteries are not the cause because i tried (b)(6) batteries and it still smells bad and gets hot.It has to do with the sensor or the device itself.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8785242
• MDR Text Key: 151021916
• Report Number: MW5088043
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE
• 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
• Patient Weight: 24