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

Model Number M042

Device Problems Defective Component (2292); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Purchased a new malem ultimate bedwetting alarm from (b)(6).The alarm is defective.It is unusually hot when batteries are inserted.I had the alarms in my hand and it was so hot that it burnt my fingers.I am very scared and disappointed to use this alarm.My son is only (b)(6) and to think that he will be using this alarm at night is not possible.This alarm will burn his skin.I will not use it as it is dangerous.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8712226
• MDR Text Key: 148542785
• Report Number: MW5087445
• 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
• Type of Report: Initial
• Report Date: 06/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• 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: 5 YR
• Patient Weight: 20