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

Model Number M04SB

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 10/09/2018

Event Type  Injury  

Event Description

This complaint is being written on the advice of the clinic my son was admitted to last night.This enuresis alarm produced a large amount of heat and burnt him.We were late to remove the alarm and it scarred his skin.It is rather unfortunate that the alarm did that.The alarm has only been used for one night.The two batteries that are housed in the alarm also leaked out from the alarm like they short circuited.The alarm plastic has bent from heat inwards like the plastic nearly melted and fused on my son's skin.We are afraid of using the alarm and have left it with the clinic.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS - ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7960239
• MDR Text Key: 123675327
• Report Number: MW5080511
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SB
• Device Catalogue Number: ROYAL BLUE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 28