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

Model Number M04S

Device Problems Fluid/Blood Leak (1250); Melted (1385); Battery Problem (2885)

Patient Problem Burn, Thermal (2530)

Event Date 03/10/2018

Event Type  Injury  

Event Description

Two weeks ago, a parent brought in her (b)(6) son.The boy was burnt in the neck from a malfunction in an enuresis alarm.Pt said that the alarm was purchased new and it was the first night the alarm was used.She brought in the alarm along with her son.The boy was given appropriate treatment and the alarm has been returned back to the parent.The back of the alarm has partially melted from a malfunction and the batteries have leaked out.The heat and battery leak has burnt the child.The alarm was being operated under normal conditions and was in use for under 1 hr when the malfunction happened.Child is recovering and has burn marks on neck.

• Brand Name: MALEM MEDICAL ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL ; lowdham ; UK
• MDR Report Key: 7372903
• MDR Text Key: 103600122
• Report Number: MW5076105
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2018
• 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): Hospitalization; Other
• Patient Age: 8 YR