MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BED WETTING ALARM

Model Number MO5S2

Device Problems Melted (1385); Overheating of Device (1437); Fumes or Vapors (2529)

Patient Problem Burn, Thermal (2530)

Event Date 12/30/2016

Event Type  Injury  

Event Description

This is the second time this particular brand of nocturnal alarm has an adverse effect on the pt.I have prescribed nocturnal enuresis alarms in conjunction with ddavp.In the last 2 months, this is the second time the malem brand of enuresis alarms has overheated and plastic housing melted while pt was wearing the alarm in sleep.Pt has recorded child put on a alarm and within few hours, the alarm overheated and started fuming.Confused child removed the alarm before severe damage.The child has only suffered minor burn injuries, which is consistent with the other recorded case.I had prescribed this alarm to the parent and several others.I routinely prescribe nocturnal anuresis alarms to my pts and this was probably prescribed in early (b)(6) 2016.

• Brand Name: MALEM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nothingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6224790
• MDR Text Key: 64031532
• Report Number: MW5067034
• Device Sequence Number: 1
• Product Code: KPN
• 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: 01/03/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO5S2
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 6 YR
• Patient Weight: 22