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

Model Number M043

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/15/2019

Event Type  Injury  

Event Description

Alarm received in new and unused condition is defective on arrival.It is hot to touch when i insert batteries.I put in batteries and started reading the instructions which are too complicated, 20 mins later, the alarm was burning my hands.Confused, not knowing what to do, i removed the batteries and that cooled the device down.I then reinserted the batteries and the alarm again got hot.I worry that the alarm will catch fire or hurt.It is so hot that it is extremely dangerous to use.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: 8717391
• MDR Text Key: 148810193
• Report Number: MW5087489
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M043
• 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