MAUDE Adverse Event Report: MALEM MEDICAL ,LTD MALEM ULTIMATE BEDWETTING ALARM; ALARM, CONTITIONED RESPONSE ENURESIS

Model Number M044

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 02/04/2019

Event Type  Injury  

Event Description

Child has suffered burns on chest area from bedwetting alarm.She was sleeping at night when the alarm has overheated and burnt her.We are surprised and depressed that she has had to stuffer for no fault of hers.The alarm just got so hot at night that it burnt her neck.She was screaming in pain when this happened and we feel responsible for subjecting her to this treatment.We took her to the er for treatment at night and they treated her and suggested we contact fda for reporting this incident.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONTITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL ,LTD
• MDR Report Key: 8331670
• MDR Text Key: 136136916
• Report Number: MW5083906
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/07/2019

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: M044
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR