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

Model Number M05SC

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 12/26/2018

Event Type  Injury  

Event Description

My son was sleeping with his bedwetting alarm and he was injured.The alarm was hot and burnt his neck at the point of contact.This is worrisome as it was the second night it was used.Had i not intervened to check on him, the alarm may have caused more harm on his skin.There is clearly a defect that caused the device to act this way.Not something we did wrong.For us, all we did was power on the device and place it on my son, completely dry.

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8208555
• MDR Text Key: 131981403
• Report Number: MW5082733
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05SC
• Device Catalogue Number: SELECTABLE 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: 6 YR