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

Model Number MO48TEC

Device Problems Chemical Spillage (2894); Electrical Shorting (2926)

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

Event Date 03/23/2018

Event Type  Injury  

Event Description

A young boy, aged (b)(6) years was brought into the hospital for chemical burns from battery leak.The device in question was the malem enuresis alarm.Somehow, the alarm had short circuited and the batteries leaked from the alarm on to the users skin.Child has suffered severe burns and bruises from the alarm and batteries.Was discharged after treatment.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.; nottingham ; UK
• MDR Report Key: 7376798
• MDR Text Key: 103807852
• Report Number: MW5076169
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MO48TEC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• 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; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 24