MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M04

Device Problems Burst Container or Vessel (1074); Chemical Spillage (2894)

Patient Problems Bruise/Contusion (1754); Caustic/Chemical Burns (2549)

Event Date 02/24/2018

Event Type  Injury  

Event Description

Daughter's enuresis alarm exploded in regular use and caused the batteries to leak out and spill on to her clothes and body.She has been bruised and burnt from the same.I have administered first aid treatment on her.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham, lowdham ; UK
• MDR Report Key: 7302239
• MDR Text Key: 101246332
• Report Number: MW5075546
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2018
• 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: 19