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

Model Number M042

Device Problems Overheating of Device (1437); Smoking (1585); Material Protrusion/Extrusion (2979); Device Fell (4014)

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

Event Date 10/16/2019

Event Type  Injury  

Event Description

This alarm is very unreliable.First time it was used, the alarm was clicking when batteries were put in place and alarm was hot within 15 mins.Next time i changed batteries.Nothing happened.Then i inserted the sensor and it did not make the clicking sound, but there was smoke from the alarm.It seemed like it was on fire and burning.I just felt it fall on the ground and the batteries popped right out.We are too frightened to use this alarm for safety reasons.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9224943
• MDR Text Key: 163623432
• Report Number: MW5090566
• 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: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM MODEL
• Device Lot Number: BLUE COLOR
• 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: 5 YR
• Patient Weight: 10