MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M04

Device Problem Material Rupture (1546)

Patient Problems Swelling (2091); Reaction (2414); Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 02/12/2018

Event Type  Injury  

Event Description

My daughter's enuresis alarm has short circuited during normal use.The short circuit was caused under normal operation within less than an hour of use.The result was that the batteries exploded within the alarm unit and spilled on to my daughter's neck and chin.She has had a very bad reaction to the same and it has caused severe swelling and blisters, medical facility says that it will take several weeks for her to recover.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham, gb
• MDR Report Key: 7276085
• MDR Text Key: 100413305
• Report Number: MW5075279
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M04
• 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): Other
• Patient Age: 5 YR
• Patient Weight: 18