MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problems Melted (1385); Temperature Problem (3022)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 12/07/2016

Event Type  Injury  

Event Description

Purchased malem alarm from (b)(6) after reading advertisement that said it can cure bedwetting 100 percent.Super excited to use it.Put it on my daughter at 8:30pm before her bedtime and at 9:15pm, she came down in tears that she threw the malem as it burnt her.My husband and i went back to the room and the malem alarm was super hot.The back battery door had partly melted and my daughter's neck was red from the burn.How does this company make a product that is so dangerous and advertise as a 100 percent safe cure for bedwetting.I feel betrayed as this was supposed to cure her bedwetting.We used neosporin and took her to the doctors office in the morning.He told us to contact fda and report the incident.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6194081
• MDR Text Key: 62970818
• Report Number: MW5066829
• Device Sequence Number: 1
• Product Code: KPN
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR