MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Device Problem Overheating of Device (1437)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/03/2018

Event Type  Injury  

Event Description

A (b)(6) year old boy was burnt on the neck by an enuresis alarm.Parents have brought child in for treatment.Parents said that the enuresis alarm got extremely hot at night under normal use and the heat burnt the child.In addition, the child also suffered chemical burns from battery spill.The nurse has treated the child and discharged him.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7510501
• MDR Text Key: 108223461
• Report Number: MW5077155
• 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: 05/09/2018

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: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2018
• 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): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 26