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

Model Number ULTIMATE PRO

Device Problems Overheating of Device (1437); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Burn, Thermal (2530)

Event Date 10/15/2019

Event Type  Injury  

Event Description

On (b)(6) at 9:50pm, i treated a pt for burns from using a bedwetting alarm.The pt was young female who had used alarm for the first time that night.The burns were the result of the alarm overheating and causing skin burn on contact.The alarm has been returned back to the parents, but it is important to note that the excess heat from the device has caused the plastic housing to deform.The heat was excess causing plastic to bend and injure child.The burns were minor in nature but noteworthy of reporting as child was asleep when incident happened.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9244692
• MDR Text Key: 164238218
• Report Number: MW5090683
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization
• Patient Age: 6 YR