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

Model Number ULTIMATE PRO

Device Problems Leak/Splash (1354); Overheating of Device (1437); Failure to Shut Off (2939); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  Injury  

Event Description

The report is regarding an incident from the use of a bedwetting alarm.My son was diagnosed with uti as a result of which, he started bedwetting, using a bedwetting alarm.I am a nurse and purchased a malem pro alarm and set it up as directed.I have experience with alarms but this was the first time using this particular brand.The alarm had an issue.It would not turn off even when the steps were followed.I had to remove batteries to turn it off.That did not defer me from using the alarm.I set it up for my son and put him to bed.When i checked on him 30 mins later, there was smell in his room.Clearly from something burning.I noticed that the alarm was extremely hot.He was wearing a thick sweater at night, that protected him from getting burnt.It was not possible for me to remove the alarm with my hands as it was burning hot.I had to use a towel.Then had to leave it outside the house for fear of it catching fire.Next morning when i checked, the alarm had changed shape.It was bent from excess heat and the batteries inside had leaked.This could have been very fatal for my son and i am glad i checked it on time before it caused any damage.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 9134744
• MDR Text Key: 160677451
• Report Number: MW5090098
• 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: 09/26/2019

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: No Information
• Device Model Number: ULTIMATE PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2019
• 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: 8 YR
• Patient Weight: 31