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

Model Number M043

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 05/08/2019

Event Type  Injury  

Event Description

The pt is a (b)(6) y/o male child who was injured using an enuresis alarm.The alarm is manufactured by malem medical (b)(4) and it has malfunctioned.The cause of malfunction is likely a defect in the product which caused the device to overheat under normal operation.Pt was asleep and did not wake up on time, thereby resulting in severe burns on body and neck area from hot device.The pt's skin shows burn marks as a result of contact with the device.Pt was treated at home and then admitted to the clinic for post-traumatic assistance.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: 8615996
• MDR Text Key: 145405611
• Report Number: MW5086685
• 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 Assistant
• Type of Report: Initial
• Report Date: 05/14/2019

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: No Information
• Device Model Number: M043
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 4 YR