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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Deformation (2976)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/20/2019

Event Type  Injury  

Event Description

Purchased a malem bedwetting alarm from the company and delivered on (b)(6) 2019.Used the alarm on (b)(6) 2019.The alarm did not beep when he wet the bed, instead, the alarm (part the connects to the sensor and connected on shirt) malfunctioned.The alarm heated up and burnt my nephew injuring him.Alarm was used according to the instruction manual and in new condition.The alarm has a malfunction and the heat caused the batteries to dissipate and leak from the alarm.The heat bent the battery sliding door.Boy suffered from first degree burns but was able to remove it safely before more severe damage took place.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 8671460
• MDR Text Key: 147243484
• Report Number: MW5087134
• 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: Dentist
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 21