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

Model Number ULTIMATE PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Scarring (2061)

Event Date 09/09/2019

Event Type  Injury  

Event Description

Inserted batteries and sensor.Daughter went to sleep and woke up in pain.Alarm was hot and scarred her skin.It left red marks and she was in extreme pain.This i s not a good product and certainly not a reliable one.The doctor said that this brand of alarm is known to cause problems for users by scarring skin.Bad design.Dangerous and not reliable.Fda safety report id # (b)(4).

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9117814
• MDR Text Key: 160207071
• Report Number: MW5090008
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR