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

Model Number M042-BLUE

Device Problems Overheating of Device (1437); Vibration (1674)

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

Event Date 05/14/2019

Event Type  Injury  

Event Description

Alarm is heating up constantly with inserted sensor and connected on underwear.With sensor not connected, alarm is operating ok, but the moment sensor is connected on underwear and inserted, alarm is vibrating (no moisture) and starts getting hot.In 15 mins, heat is enough to make it unsafe.Can't use on son who is (b)(6).Afraid it will injure or hurt him.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM BLUE COLOR
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8623782
• MDR Text Key: 145604390
• Report Number: MW5086725
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M042-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): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14