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

Model Number 04

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 03/07/2019

Event Type  Injury  

Event Description

After 2 nights of use, we have found that the malem alarm has been causing burn injuries to our son.He woke up 2 nights ago after first using the alarm and had a red mark on his neck.Last night, he was sleeping and complained about the alarm burning and stinging him.We noticed that it was the alarm that has malfunctioned and caused the problem.It has to be used when he is asleep.We are not sure what is wrong with the product as it was being used as described in the user manual.We are not going to use this product anymore as it is burning my son.

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8414034
• MDR Text Key: 138673844
• Report Number: MW5084828
• Device Sequence Number: 0
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 04
• Device Catalogue Number: M
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR