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

Model Number ULTIMATE

Device Problems Device Emits Odor (1425); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 07/24/2019

Event Type  Injury  

Event Description

A (b)(6) was diagnosed with skin burns and scars from adverse action to a faulty / defective enuresis alarm.The pt, a (b)(6) male used a new enuresis alarm but a fatal defect in the alarm caused it to heat up to excess temperature which injured the user.Parents had set up the enuresis alarm correctly and child went to sleep.Child was able to remove the alarm after 30 mins of placing on his shirt.The scars are minor and will heal in a few days, but the family suffered a scare.The alarm is not operational and will not respond to any batteries.The parents say that the alarm burnt out and has the odor of burning plastic when they checked it.Alarm has been given to the parents and instructed not to use an enuresis alarm.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8846845
• MDR Text Key: 153249880
• Report Number: MW5088558
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ULTIMATE
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: No
• 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): Hospitalization
• Patient Age: 6 YR
• Patient Weight: 24