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

Model Number ULTIMATE BEDWETTING ALARM

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Shock (2072)

Event Date 09/20/2019

Event Type  Injury  

Event Description

Malem is a very poor-quality bedwetting alarm that put me and my son both in a panic situation on the very first day of use.I am shocked that there is not a warning on this product that it can shock a child.We followed the instructions and made my son wear the alarm but in the middle of the night when he screamed, i ran to his room and could find my son terribly horrified.He was soaked in urine and crying loudly.He told me that the moment he wet the bed he got a strong shock on his private part.He tried pulling it and got another shock.He was crying with pain and it was hard to cool him down.We had to apply a soothing cream every hour to make him feel comfortable.It is unbelievable that this product is being sold to children.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9146203
• MDR Text Key: 161190373
• Report Number: MW5090157
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• 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: 8 YR