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

Model Number ULTIMATE ALARM

Device Problems Device Emits Odor (1425); Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Parents complained that the enuresis alarm injured child during sleep.Child was using malem brand of enuresis alarm as prevented by pediatrician.The alarm was used for the first time and developed a defect.Outside temperature of the alarm increased as child was asleep not burnt child's skin.Contact point was near neck and child has developed blister from burn.Alarm is inoperable as internal electrical components have been damaged from excess heat.Parents also complained that alarm smelled of burning plastic.Although child's injuries are minor, the incident is important to report as this is an unexpected result of the device which is to be used on sleeping children.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 9349095
• MDR Text Key: 167386381
• Report Number: MW5091196
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ULTIMATE ALARM
• Device Lot Number: NO LOT NUMBER
• 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: 5 YR
• Patient Weight: 18