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

Device Problem Overheating of Device (1437)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 01/09/2018

Event Type  Injury  

Event Description

My (b)(6) son burnt his neck with the malem bedwetting alarm.I purchased this alarm from the bedwetting store with hopes of curing my son from his bedwetting problems, instead this alarm has severely burnt his neck.We used the alarm as per instructions, however there is some major flaw in this product that it overheats automatically.I have to rush my child for treatment.I would like to know that with so many complaints online why isn't the fda taken action against this company and its substandard product.Had the fda stepped in sooner, my child would have not gotten burnt and would not have had to suffer.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7214779
• MDR Text Key: 98180108
• Report Number: MW5074739
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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