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

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Electrical Shorting (2926)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 12/07/2017

Event Type  Injury  

Event Description

A small battery powered device (enuresis alarm) exploded at night during use.There was an electrical malfunction in the product which caused the battery terminals to short out and leak onto the user's body resulting in an adverse effect.Battery leaks can be harmful to the skin if not treated on time and that is what happened in this case.The parent was unaware of the incident and when came to know about it, the child was already burnt in the chest area.A visit to the dr's clinic showed the degree of burns and reaction to skin.The pt was released after appropriate treatment but will take several weeks to recover.The leak caused blisters on the body where the alarm was connected and battery spilled.This is the third reported incident in this clinic in the year.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham NG147 EJ; UK NG147EJ
• MDR Report Key: 7159783
• MDR Text Key: 96333097
• Report Number: MW5074335
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/29/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2018
• 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: 6 YR
• Patient Weight: 28