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

Device Problem Overheating of Device (1437)

Patient Problem Discomfort (2330)

Event Date 08/15/2019

Event Type  Injury  

Event Description

I purchased a malem bedwetting alarm from (b)(6).I followed instructions in the manual and as i inserted the batteries the alarm overheated in no time at all and was so hot that i could not even hold it.I am glad that it was not connected to my daughter or it would have burnt her.I had to keep my hand under cold water for a couple of minutes and visited my doctor the next day to recover from the burn caused by this alarm.This malem alarm is faulty and should be inspected by the fda.The manufacturer doesn¿t care and now does not even pick up my phone anymore.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: 8944733
• MDR Text Key: 156329911
• Report Number: MW5089423
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention