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

Model Number M04 ULTIMATE ALARM MODEL

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Burn, Thermal (2530); Caustic/Chemical Burns (2549)

Event Date 08/02/2018

Event Type  Injury  

Event Description

Son has primary nocturnal enuresis.Dr has prescribed an enuresis alarm, the malem brand.It has been used for only 3 nights and last night the alarm functioned erratically.Besides making a tapping wound from the inside, the alarm got hot.The heat was very high and it burnt my son's neck.This is the first time that an incident has taken place with this alarm.We have used it for last 2 days and it did nothing like that.Excessive heat has also deformed the battery casing and it has bent inwards.My son suffered minor burns but they were very close to his neck.The batteries also leaked from the alarm.Something in the alarm short circuited.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7769622
• MDR Text Key: 116710898
• Report Number: MW5079013
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/03/2018

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: No Information
• Device Model Number: M04 ULTIMATE ALARM MODEL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2018
• 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
• Patient Age: 6 YR
• Patient Weight: 24