MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problem Failure to Osseointegrate (1863)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

The product i am complaining about is a bedwetting alarm, but is marketed as a potty training product by the mfr, a (b)(6) company.The product has small parts (battery door) which can fall off and can be a choking hazard for children.There have been a number of reports where children have swallowed the battery door and this has resulted in choking.Many children have been rushed to the hospital.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 5018219
• MDR Text Key: 23608225
• Report Number: MW5055542
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 08/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 3 YR