MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Leak/Splash (1354); Overheating of Device (1437); Battery Problem (2885)

Patient Problems Rash (2033); Burn, Thermal (2530)

Event Type  Injury  

Event Description

I purchased the malem ultimate bedwetting alarm from the (b)(6).On the very first night the alarm overheated and batteries leaked causing burns on my son.He was first hospitalized for skin burns and after several weeks now till date, he is being treated for rash from the battery leak.I request the fda to look into this matter asap.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL UK; UK
• MDR Report Key: 7471878
• MDR Text Key: 106876201
• Report Number: MW5076814
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24 YR