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

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

Patient Problem No Information (3190)

Event Date 01/17/2019

Event Type  Injury  

Event Description

Ever since we have received the bedwetting alarm, the device just fails to operate correctly.Upon placing the device on pt, the alarm warms up and is untouchable by hand.Excess heat from the device.Initially pt thought that this was the cause of defective batteries but changing batteries did not improve the situation.The device warms up no matter which batteries are inserted.Knocking noise from inside the device indicates a failure or stuck mechanical component.Child is too scared to use further bedwetting alarms for treatment and is psychologically afraid to try other remedies.Family does not want info disclosed to mfr.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8270896
• MDR Text Key: 134018652
• Report Number: MW5083300
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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