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

Model Number M041

Device Problems Overheating of Device (1437); Defective Component (2292)

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

Event Date 04/14/2019

Event Type  Injury  

Event Description

My (b)(6) y/o son was hurt while he was sleeping with his bedwetting alarm.This alarm has a serious defect which caused the problem.I set up the device and my son was in pain 30 mins into his sleep because he was burnt by the alarm.Although not serious, the incident was worth reporting as it's a reliability issue with the alarm that made it overheat and injure my son.He has suffered skin burns and this is a traumatic experience for him.He is in shock and scared to use an alarm for his enuresis treatment.This system has actually cause more damage than benefit.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; nottingham ; UK
• MDR Report Key: 8527477
• MDR Text Key: 142496836
• Report Number: MW5085963
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M041
• Device Catalogue Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other