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

Model Number M-05-S

Device Problems Overheating of Device (1437); Electrical Power Problem (2925)

Patient Problem Burn, Thermal (2530)

Event Date 03/22/2019

Event Type  Injury  

Event Description

Our office treated a patient who was injured by a bedwetting alarm.The patient was a (b)(6) year old male child and parents have said that the cause of injury was a malfunctioning enuresis alarm.The alarm was not incorrectly used according to parents.They installed it correctly and put the child to sleep.A few hours later (1-2 hours, they can't exactly remember), the child complained of extreme heat and severe burns on skin.The alarm has malfunctioned as a result of electronic failure.The patient was discharges after administering minor burn treatment.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8465535
• MDR Text Key: 140443122
• Report Number: MW5085360
• 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: 03/25/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M-05-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• 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 Age: 4 YR