MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number MO4S2

Device Problem Break (1069)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

On (b)(6), i was informed that a child had swallowed a small part of a product intended for use by children.It appears that the parent had put on the product to potty train their child and when the product fell, the battery door snapped out and was swallowed by the child.The small part was stuck in the child's neck and required medical intervention to be removed.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; fulton MD 20759
• MDR Report Key: 5741476
• MDR Text Key: 48018493
• Report Number: MW5062969
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MO4S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 16