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

Model Number ULTIMATE

Device Problems Crack (1135); Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problems Burn, Thermal (2530); Electric Shock (2554)

Event Date 05/15/2019

Event Type  Injury  

Event Description

Pt is a (b)(6) boy.Pt has adhd and suffers from primary nocturnal enuresis.A dual therapy of ddavp and an enuresis alarm was prescribed.Pt's family purchased a malem ultimate bedwetting alarm from (b)(6).The alarm has injured the pt while he was asleep.Pt claims the alarm shocked him and burnt him in the neck as a result of internal malfunction.Pt was asleep for under 30 mins when incident occurred.Alarm was returned back to parents after they brought in child for treatment.The alarm housing (plastic case) has cracked from heat and bent inward.Alarm is no longer operational.Pt was treated for first degree burns and discharged.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 8640608
• MDR Text Key: 146232992
• Report Number: MW5086888
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 6 YR
• Patient Weight: 24