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

Model Number

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 08/15/2018

Event Type  Injury  

Event Description

I chose to buy a malem bedwetting alarm for my (b)(6) daughter as it claimed to cure nighttime bedwetting but, in their instructions, they never wrote that it can damage your child's skin if you use it for more than two hours.On the first day of using it, my daughter got big burn marks on her neck.The burns were extremely painful for her and us.This kind of product needs to be taken out of the market completely before it causes more harm to children.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; 17737 new hamshire ave; ste 100; ashton MD 20861
• MDR Report Key: 7850355
• MDR Text Key: 119502543
• Report Number: MW5079586
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient

Device Model Number

Device Catalogue Number

Device Lot Number

• 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