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

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Pt is a (b)(6) girl who was diagnosed with nocturnal enuresis.Dr prescribed an alarm for treatment.Pt used the alarm for 3 nights unsuccessfully.On the fourth night, pt had an incident with the alarm.The pt went to bed with the alarm set up, but woke up parents from loud cries.Mother heard cries and found that pt had received burns on skin near neck area from the alarm.The alarm has developed a defect which made it become hot.Pt's mother pulled out the alarm and in the process hurt her hands from the heat.The child was taken to a nearby clinic for treatment of burns and is recovering.The alarm has been returned to the mfr.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8293034
• MDR Text Key: 134610462
• Report Number: MW5083560
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 21