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

Model Number SINGLE TONE

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

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

Event Date 02/28/2019

Event Type  malfunction  

Event Description

Bedwetting alarm is getting too hot to use.Received it new today and tried using it for the first time but the back and bottom is too hot to hold and operate safely.This is designed to be used by a child in his sleep.Doesn¿t seem possible to use by my son who is (b)(6) without causing some serious injury.We can¿t use the bedwetting alarm as is without wrapping it in cloth because the heat is too much and there is burning plastic smell coming from the inside of the alarm too.

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8386197
• MDR Text Key: 137796472
• Report Number: MW5084590
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SINGLE TONE
• Device Catalogue Number: RED COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR