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

Model Number ULTIMATE SELECTABLE

Device Problems Vibration (1674); Temperature Problem (3022)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 01/29/2019

Event Type  Injury  

Event Description

My son was sleeping in his room last night with his malem alarm and he complained of skin irritation 30 minutes later when i checked on him.He said that the alarm was stinging him on his neck.I checked and realized that the malem alarm was slightly warm and vibrating erratically.I removed the sensor but it did not stop the vibration.After some time, the alarm got warmer and i removed batteries.I replaced it with new (b)(6) batteries, but same thing happened.No matter which batteries i put, the malem alarm kept vibrating like there was something stuck inside.My son has minor skin irritation from use but the alarm is not working as expected and getting warm.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED , RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8296922
• MDR Text Key: 135436143
• Report Number: MW5083613
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE SELECTABLE
• Device Catalogue Number: BLUE
• 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): Other
• Patient Age: 5 YR