MAUDE Adverse Event Report: MALEM MALEM BED WETTING ALARM

Model Number M04SC

Device Problems Leak/Splash (1354); Material Deformation (2976); Temperature Problem (3022)

Patient Problems Erythema (1840); Skin Irritation (2076); Swelling (2091); Injury (2348); Caustic/Chemical Burns (2549)

Event Date 08/18/2017

Event Type  Injury  

Event Description

This complaint is to report chemical burns from batteries leaks in a bedwetting alarm.The malem bedwetting alarm we purchased barely a week ago has had a major electrical failure.It was set up properly at night as per all instructions and directions.It was placed on my daughter's underwear with the clip on the outside and the cord running under her shirt.The alarm was secured on her collar so it would be secure through the night and would not come off.My daughter went to sleep at 8:45pm on friday evening.At 11:25pm, barely 2hr and 45 minutes of use, we heard our daughter crying loudly.We are in the adjacent room and we went over quickly and noticed that there was black liquid all over her chest and neck.She was screaming take it off, take it off.We tried pulling the alarm from her collar, but it would not come off.We had to reach the back of alarm unit which was extremely hot.My husband had battery acid all over his fingers.The acid leaking out of the battery compartment spilled over to my daughter's neck and chest as well.Because of this, she suffered minor burns and serious skin irritation.Her neck started swelling within minutes.I noticed that the battery door had deformed from the heat and was completely soaked in battery acid.We took her to the nearby clinic where they treated her.She was also given a shot to help prevent any infection.The next day, the minor burns had turned patchy red and small blister like formations on her neck and chest.We were told to report the incident to the fda by the clinic.This alarm was used for under 3 hours and has caused serious damage to my daughter's health and mental well being.We are afraid to try any new product around her now.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: MALEM BED WETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6812588
• MDR Text Key: 83318161
• Report Number: MW5071735
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/21/2017

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: Health Professional
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2017
• 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; Life Threatening; Other
• Patient Age: 6 YR
• Patient Weight: 23