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

Model Number M04

Device Problems Leak/Splash (1354); Melted (1385); Material Twisted/Bent (2981); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Patient is a (b)(6) child who was diagnosed with primary nocturnal enuresis.Parents were recommended to use an enuresis alarm for the treatment.The enuresis alarm has caused burns on the child¿s skin where it was touching at night.Child has small burn marks and red patches on neck and chest area.The alarm has leaked out batteries and the battery has spilled on child¿s clothing and body.Backside of the alarm which touches the skin has visible heat lines (stretch line) and the battery door has changed shape from heat.It has bent inwards from excess heat.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 8119661
• MDR Text Key: 129060422
• Report Number: MW5081737
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Device Catalogue Number: ROYAL BLUE
• Device Lot Number: NONE
• 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
• Patient Age: 6 YR
• Patient Weight: 19