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

Model Number ULTIMATE

Device Problem Overheating of Device (1437)

Patient Problems Rash (2033); Swelling (2091); Skin Inflammation (2443)

Event Date 10/12/2019

Event Type  Injury  

Event Description

Excess heat from repeated use of the alarm over a period of 5 days has caused severe skin rash in (b)(6) year old boy.There is redness and swelling at places where the alarm is connected on the pt especially the neck area.I have inspected the alarm and it is clear that the skin rash is a result of heat from the alarm when it contacts the skin.This excess heat is not normal.Although it is not excess in this alarm, it is significant to cause skin rash.Child was using the alarm for 5 days before the cause could be isolated to the alarm.Stopping use of the alarm for 2 days has already improved child's skin.Holding the alarm in hands when powered on, i can feel heat.This is clearly the cause of skin rash.Heat by itself is unlikely to do this, unless there is a contaminant on the product.Fda safety report id#: (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; nottingham ; UK
• MDR Report Key: 9197480
• MDR Text Key: 162701194
• Report Number: MW5090422
• 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: 10/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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: PRO
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 22