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

Model Number BEDWETTING ALARM

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Skin Irritation (2076); Swelling (2091)

Event Date 06/12/2019

Event Type  Injury  

Event Description

Using the malem bedwetting alarm to help with nighttime bedwetting.After 1 week of continued use, son developed red patches on skin where alarm was placed.Discontinued use and the redness went away.Retried the alarm and noticed that the redness is from excess heat coming from the alarm.This was not evident under normal use, but when sensor is placed under water with sensor plugged into alarm, then alarm gets hot on backside.We have suffered for a week without knowing it was the alarm causing this redness and swelling.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: 8735441
• MDR Text Key: 149486075
• Report Number: MW5087627
• 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: 06/23/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BEDWETTING ALARM
• Device Catalogue Number: ULTIMATE
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR