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

Model Number ULTIMATE PRO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Scarring (2061); Skin Inflammation (2443)

Event Date 07/19/2019

Event Type  Injury  

Event Description

Son has developed a reaction to the malem alarm which he places on him at nighttime just before sleeping.To assist with his bedwetting, we have tried several techniques including alarms.The dr recommended malem but it has not functioned correctly.My boy is getting red scars and patches on his neck around the right side.This is where the alarm is placed, it could be from the heat of the alarm or the plastic.I am not sure.But the marks are prominent and it is itching him severely.Have discontinued using the alarm and spoke to the dr who instructed us to complain here.Alarm is left with dr.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8826249
• MDR Text Key: 152314127
• Report Number: MW5088355
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR