MAUDE Adverse Event Report: NIGHT HAWK; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Mechanical Problem (1384); Electrical Shorting (2926); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 10/19/2018

Event Type  Injury  

Event Description

We were prescribed an enuresis alarm by my daughter's pediatrician.We used a night hawk alarm for 2 months with little to no success.Then we were advised to switch brands and use a malem alarm.It has been a horrible experience.At least the night hawk alarm did not burn our child.The malem has been erratic since the first night we used it.The first night it was used, we noticed that the alarm was getting warm when the sensor was connected.We did not use it that night.The second night, the same thing happened and we thought it was normal for an electronic device to warm up a bit when used.But the alarm is actually dangerous.My daughter was crying in pain when we reached her.The alarm had burnt her in her neck.When we examined the alarm, its plastic case had bent from heat and the batteries had leaked inside the alarm.There is a mechanical and electrical issue with this product.How can a device burn a child who is sleeping on their neck? i can understand a failure after months of use if it were dropped, but this device was 2 days old.My daughter was taken to the emergency room in the middle of the night.We never want to have to deal with this again.She is terrified and so are we.The alarm has been left with the hospital.

• Brand Name: NIGHT HAWK
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• MDR Report Key: 7999276
• MDR Text Key: 124968013
• Report Number: MW5080754
• Device Sequence Number: 2
• 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: 10/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 19