MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M04S

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Caustic/Chemical Burns (2549)

Event Date 10/02/2017

Event Type  Injury  

Event Description

Reporting adverse event with an enuresis alarm.The child was burnt and bruised with the malem enuresis alarm.Source of burns were chemical burns from battery leak.The alarm has malfunctioned and caused batteries to leak into clothing.Child tried to remove the alarm and in the process battery acid has leaked on to the child's hands.Child accidently placed hands in mouth and swallowed battery acid.The child has minor burns from alarm and bruises on neck area.The child also has been treated for accidental battery acid consumption.Child was admitted to er and discharged after observation the next day.Currently the child is visiting doctor for treatment with blisters and burns.The enuresis alarm is in our possession and it appears that the cause of malfunction was the alarm itself.The heating and battery leak also caused the alarm battery door to bend inward and melt.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 6940162
• MDR Text Key: 89173574
• Report Number: MW5072671
• 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: 10/05/2017

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
• 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: 10/11/2017
• 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): Life Threatening
• Patient Age: 7 YR
• Patient Weight: 29