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

Device Problem Device Alarm System (1012)

Patient Problem Burn, Thermal (2530)

Event Date 03/11/2019

Event Type  Injury  

Event Description

My office has been treating pts with nocturnal enuresis for several decades.Recently a pt who we recommend use an enuresis alarm complained that the alarm had malfunctioned and injured the child at night.I requested that they bring in the child for immediate treatment.The parents showed me the alarm which had caused injuries and the cause can be attributed to the alarm.The child was asleep when this incident happened and did not wake up on time.This was the reason that the device probably caused the skin burn in the child.I treated the child for minor burns on the neck area and the alarm was returned back to the parents.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8452610
• MDR Text Key: 139993621
• Report Number: MW5085151
• 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: Physician
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 8 YR