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

Model Number ULTIMATE ALARM

Device Problems Overheating of Device (1437); Defective Component (2292)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

The bedwetting device is defective.It's unstable and gets hot when the sensor is inserted inside it.I replaced the batteries too, but that didn't help.With batteries inserted, the device is on and heats up a little bit on the outside.However, when the sensor is inserted (lever up or down, doesn't matter), the device external temperature rises rapidly till it goes from warm to hot.As i was holding it in my hand, i felt it heat up and got very hot.Not safe to operate or hold.I retried the next night with fresh batteries, but the same thing happened; 4 sets of batteries can't be faulty.Defect is in the device.Just unsafe.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING DEVICE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9580861
• MDR Text Key: 175092761
• Report Number: MW5092164
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: 8 TONES - SELECTABLE
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR