MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ALARM, CONDITIONED REPONSE

Model Number M034

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Component (2292)

Patient Problems Pain (1994); Reaction (2414); Burn, Thermal (2530)

Event Date 02/02/2019

Event Type  Injury  

Event Description

The incident has taken place in a (b)(6) year old girl who was diagnosed with primary nocturnal enuresis.Pediatrician prescribed an enuresis alarm for treatment.Parents purchased online at (b)(6) website.The enuresis alarm has had a severe adverse event first night of use.Parents had watched instructions and use videos for the enuresis alarm prior to setup and followed all instructions.After setting up at night, girl was asleep with alarm connected on underwear and t-shirt.An hour later, girl was in severe pain and crying when parents checked on her.She had removed the alarm which was buzzing and vibrating.The girl had not had a bedwetting incident at night, but the alarm had falsely detected bedwetting and started buzzing.The defect in the product made the device overheat and the heat from the device burnt the girls skin.She was taken to our clinic for treatment and we observed that the alarm was responsible for failure and cause of burns.Extreme heat has made the internal plastic change shape and batteries leak on child¿s skin.The heat and battery acid has had an adverse reaction on girl.Alarm has been returned to parents.Yellow 8 random tone.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED REPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8336695
• MDR Text Key: 136532885
• Report Number: MW5083995
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M034
• 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; Required Intervention
• Patient Age: 8 YR