MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Catalog Number NONE

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

My son got burnt with the malem bedwetting alarm.I purchased this alarm last week from the (b)(6).All we did was connect the alarm to his collar to monitor his bedwetting events and the alarm got super hot.His burns are severe.We tried some home remedies at first but had to resort to going to the doctor eventually.Till date my husband and i have bought countless products but nothing this inferior and unstable like the malem alarm.This is not acceptable.Such faulty products need to be removed from all households in the us.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6995725
• MDR Text Key: 90940925
• Report Number: MW5073075
• 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
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR