MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL; BEDWETTING

Model Number M04S

Device Problems Leak/Splash (1354); Overheating of Device (1437); Sticking (1597)

Patient Problems Shock, Traumatic (2268); Caustic/Chemical Burns (2549); Chemical Exposure (2570)

Event Date 10/09/2017

Event Type  Injury  

Event Description

After just 3 nights of use, the bedwetting alarm my son used has malfunctioned and seriously hurt my son.In the early hours of the night, when my son was asleep, the vibration part of the alarm that makes the alarm shake got stuck.When my son wet the bed, the vibration part because it got stuck, started generating a lot of heat.The heat was excessive and my son was asleep.The alarm heated so much that the batteries leaked out and exploded.My son was covered with dangerous battery liquid and suffered chemical burns.The heat also caused the plastic casing of the alarm to melt.He has to be taken to the er for immediate attention.He has suffered post traumatic shock from the malfunction and very serious burns on his neck area.After treatment, these burns have left big red scans on his neck.

• Brand Name: MALEM MEDICAL
• Type of Device: BEDWETTING
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6971147
• MDR Text Key: 90166724
• Report Number: MW5072890
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• 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): Hospitalization
• Patient Age: 8 YR
• Patient Weight: 39