MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M0S

Device Problems Material Disintegration (1177); Leak/Splash (1354); Material Deformation (2976)

Patient Problem Burn, Thermal (2530)

Event Date 07/04/2017

Event Type  Injury  

Event Description

Three nights ago, a patient came to the emergency room at 2:15 am.Her (b)(6) son was burnt on his neck.She believed the burns were from a bed-wetting alarm she had used for her son.The alarm was also brought to the hospital.I administered treatment to the patient.The alarm has a critical design flaw in my opinion.The back casing of the alarm had disintegrated from heat and the battery housing lid was deformed.The batteries had also leaked out like there was a minor explosion with the alarm.Unfortunately the child has burns on his neck, chest and hands.He is undergoing treatment and will recover.The mother has taken the bed-wetting alarm back to be returned to the manufacturer.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6700722
• MDR Text Key: 79757253
• Report Number: MW5070885
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M0S
• Was Device Available for Evaluation?: No
• 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): Hospitalization; Other
• Patient Age: 8 YR