MAUDE Adverse Event Report: MALEM MEDICAL & BEDWETTING STORE MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Lot Number NONE

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Pain (1994)

Event Type  Injury  

Event Description

I bought two malem bedwetting alarms from the (b)(6) for my twins.The first time we connected the alarm to my son.It burnt him on his neck.We had to rush him for treatment.The pain was excruciating and the burns were severe.I was lucky that day not to have connected the second alarm on my daughter.When we tried and tested the second alarm later, we noticed that it started getting hot as well.We tossed both alarms in the garbage.I demand an answer.When i was writing this complaint, i noticed similar complaints online then why has the fda not recalled this product as of yet."are we waiting for life threatening event to take place.".

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL & BEDWETTING STORE
• MDR Report Key: 6998747
• MDR Text Key: 91063704
• Report Number: MW5073111
• 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: 10/31/2017
• 2 Devices were Involved in the Event: 1 2

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 Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR