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

Model Number ULTIMATE

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 08/06/2019

Event Type  Injury  

Event Description

The malem alarm (enuresis device) has a serious defect.Upon installing batteries, it's getting very hot.There is a rattling noise when the alarm is shaken.It was secured on my child and they complained of it smelling bad.I removed the device and immediately noticed it was warm and gradually got hotter and hotter.Even i, being an adult was unable to hold it in my hands from risk of getting burnt.It's not related to batteries as they have been replaced.The alarm itself has flaws making it too dangerous to be worn by my child.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD. ; UK
• MDR Report Key: 8883411
• MDR Text Key: 154106428
• Report Number: MW5088936
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Required Intervention