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

Model Number M04S

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problems Bruise/Contusion (1754); Erythema (1840)

Event Date 07/30/2018

Event Type  Injury  

Event Description

A girl came into the clinic early in the morning at 5:30 am with her parents.She had been bruised by a hot object placed on her neck.The object was a regular enuresis alarm.The brand was malem.The girl had big red patches on her neck clearly from the alarm exploding.Parents said that the device was used as per directions and they had just recently purchased it from the internet.The child's clothes were stained with battery leak.We discharged the child after appropriate treatment and have recommended f/u.The use of the enuresis alarm has been discontinued for safety reasons.It was returned back to the parents at their request.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 7746447
• MDR Text Key: 116060459
• Report Number: MW5078833
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2018
• 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: 8 YR
• Patient Weight: 28