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

Catalog Number M04SC

Device Problems Leak/Splash (1354); Temperature Problem (3022)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 12/15/2018

Event Type  Injury  

Event Description

Daughter injured from burns caused by defective bedwetting alarm.Alarm was hot when we found out.Batteries leaked out from back and underside of the alarm.Child freighted and in pain from burns.Alarm is unusable from heat and battery leak.Operated as per instructions.Defective device.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8197086
• MDR Text Key: 131733458
• Report Number: MW5082594
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: M04SC
• 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