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

Model Number ULTIMATE BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 03/17/2020

Event Type  Injury  

Event Description

My son was asleep on his first night with the bedwetting alarm.He woke up to burning plastic smell and a very hot alarm which burnt his neck and left a red patch.I contacted the company numerous times, they did not bother responding.This alarm is dangerous and very unsafe.My son is just (b)(6) and he was injured in his sleep.Fda safety report id # (b)(4).

• Brand Name: ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9865358
• MDR Text Key: 184812147
• Report Number: MW5093883
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BEDWETTING ALARM
• 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: 5 YR