MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Burn, Thermal (2530)

Event Date 09/19/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm is an inferior and poorly designed product, that gets hot like an iron.We used this product on my son for just 4 hours and the alarm burnt him on his neck.This product has some serious problems and must be recalled from the us market.My son received treatment from our family physician but the burn marks still persist.I bought this alarm from (b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6993372
• MDR Text Key: 90847827
• Report Number: MW5073058
• 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: 10/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR