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

Model Number ULTIMATE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530)

Event Date 05/07/2019

Event Type  Injury  

Event Description

For the treatment of nocturnal enuresis, we prescribed a nocturnal enuresis alarm to parents for child.The pt is a (b)(6) male with chronic enuresis and diabetes.Parents were demonstrated on the setup instructions of the alarm and were trained.However, the alarm has failed during normal operation.The child was asleep when the alarm shorted itself and burnt the child.The child woke up and called for parents' help and they promptly removed the alarm.The pt has very minor bruise at the alarm contact point; however, the trauma has scared him and he and his parents have refused to continue alarm treatment.Pt was not admitted to the clinic for treatment but did come in for consultation.Parents have reached out to the mfr and prefer to remain anonymous.The alarm was inspected by the clinic and it was evident that the cause of failure was electrical from the alarm.The plastic box that holds the electronics has thinned out from excess heat.Fortunately the child was not seriously injured.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8612326
• MDR Text Key: 145245965
• Report Number: MW5086646
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 4 YR
• Patient Weight: 19