MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM; BED-WETTING ALARM

Model Number MALEM 05

Device Problem Expulsion (2933)

Patient Problem Injury (2348)

Event Date 01/04/2016

Event Type  Injury  

Event Description

A (b)(6) male child with primary nocturnal enuresis was prescribed an enuresis alarm.The enuresis alarm exploded near the child's neck and had to be given assistance from a medical practitioner.Product seems to have either overheated or battery discharge.Patient was only using the enuresis alarm at the time.The product has had an adverse effect on child by exploding near the neck.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: BED-WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; fulton MD 20759
• MDR Report Key: 5366122
• MDR Text Key: 35943527
• Report Number: MW5059289
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MALEM 05
• Device Lot Number: NOT ON BOX/PRODUCT
• Other Device ID Number: NONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 22