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

Model Number ULTIMATE BLUE ALARM

Device Problems Overheating of Device (1437); Difficult to Remove (1528)

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

Event Date 10/04/2019

Event Type  Injury  

Event Description

The malem alarm was used by my daughter on the advice of her teacher.My daughter has a bedwetting problem and i wanted to get her something that would train her.I called bedwettinstore.Com and they said that this particular alarm was best for morning and night bedwetting detection and treatment.It uses a sensor and alarm which is placed on her shirt, i set it up exactly like that and my daughter was in preschool.Her teacher called and said that she had an accident.She was asleep in recess with the alarm and wet herself.The alarm was on vibration so there was no sound.It kept vibrating, but she did not get up.After 20 mins, she was crying and the teacher said that the alarm was so hot that it was like it were on fire.The teacher said that for my daughter's safety, she had to remove her shirt as she was unable to remove the alarm from it and tossed it outside.Teacher also said that the alarm made a hole in the shirt.This is completely unacceptable.Extremely dangerous and we are so frightened.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9172423
• MDR Text Key: 161799191
• Report Number: MW5090287
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BLUE 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: 4 YR