MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problem Overheating of Device (1437)

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

Event Date 10/19/2017

Event Type  Injury  

Event Description

I purchased the malem bedwetting alarm online from the bedwetting store.When i connected it for the first time on my (b)(6) y/o daughter, it overheated and burnt her on her neck.She suffered severe burns and had to be rushed to her primary care physician in the middle of the night.It's been a few days now, however, the burn marks haven't gone and she keeps getting pain periodically.I demand an answer, "why is such a flimsy and substandard being sold here in the us." this product must be recalled and the mfr should be penalized for selling such a product.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7048130
• MDR Text Key: 92637427
• Report Number: MW5073420
• 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: 11/16/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR