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

Device Problems Overheating of Device (1437); Defective Device (2588)

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

Event Date 10/25/2019

Event Type  Injury  

Event Description

Alarm is consistent and not operating correctly.Uses 2 aaa batteries; however when batteries are in the alarm, it's unusable because the outside temperature is exceeding safe operating temperature.There is clearly an electrical issue with the system because its temperature is increasing within mins of batteries being inserted.I have also tried to change the batteries and brand.Nothing helps.With temperature like this, the alarm will injure the user in seconds on skin contact.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9255236
• MDR Text Key: 164618444
• Report Number: MW5090757
• 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: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 6 YR
• Patient Weight: 27