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

Device Problems Fail-Safe Design Failure (1222); Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/03/2017

Event Type  Injury  

Event Description

Pt came to emergency room complaining of neck burns to the child.The child has suffered minor burns around the neck from an overheating medical device.The child was given appropriate attention and discharged.The reason was the children's product (enuresis alarm) had overheated and melted the back of the alarm posing a health hazard and risk to pt.This was the initial night that the product was used.The product was purchased at bedwettingstore.Com.

• Brand Name: MALEM MEDICAL
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL ; lowdham, nottingham NG14 7EJG; UK NG14 7EJGB
• MDR Report Key: 6242082
• MDR Text Key: 64603343
• Report Number: MW5067167
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 24