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

Model Number M04SB - ROYAL BLUE

Device Problems Break (1069); Vibration (1674); Defective Component (2292)

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

Event Date 06/04/2019

Event Type  Injury  

Event Description

The malem ultimate alarm is defective and dangerous.After using it for 2 nights, the sensor broke.The company sent a replacement.This caused more problems.I used it just as we did the first two nights, but this time, when the sensor was inserted into the alarm, it started to make short vibration as if there was something stuck inside the device.I did not worry too much about it and this was a mistake.The alarm has injured and burnt my son in 30 mins.The burns are severe and resulted in small red spots on his neck.This is just unacceptable.How can it burn skin on contact? we stopped using the alarm and disposed it.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CODITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8691859
• MDR Text Key: 147938458
• Report Number: MW5087277
• 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: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SB - ROYAL BLUE
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• 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