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

Model Number ULTIMATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

As a pharmacist i often teach pts how to use an enuresis alarm.I purchased one for my son and it has malfunctioned.He has developed a severe skin rash from using the enuresis alarm over a period of 5 nights.The root cause of this is the heat generated by the enuresis alarm when it detects urine and starts to keep and vibrate.Otherwise, it is normal and looks fine.But once urine is detected, it gets warm.The rash is on his neck where the alarm is connected and in contact with his skin.It's a severe rash and i have discontinued use as this is not a side effect expected by using an enuresis alarm.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONES ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 9591555
• MDR Text Key: 175479897
• Report Number: MW5092232
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 01/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: 1 TONE PRO
• Device Lot Number: MISSING
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1