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

Model Number ULTIMATE PRO 1 TONE

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 12/25/2019

Event Type  Injury  

Event Description

When i am inserting sensor inside the alarm portion of the device, the alarm starts to vibrate and then gets hot.After a few mins, starts to smell of burning plastic.This is not how the device should operate.It should only vibrate when urine is detected.It should not get hot and should not smell of burning plastic.These are abnormal traits that the device is defective.The outer body temperature is significant and it's really very hot.I worry that the heat will melt the plastic casing.Also, fumes from the alarm portion of the device could be harmful when used on a child.Fda safety report id # (b)(4).

• Brand Name: ENURESIS ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9535513
• MDR Text Key: 173286780
• Report Number: MW5091939
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO 1 TONE
• Device Catalogue Number: BLUE COLOR 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: 8 YR