MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Lot Number NONE

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/14/2017

Event Type  Injury  

Event Description

My daughter who is (b)(6) apparently swallowed the malem alarm's battery door.She was lucky to have coughed it out in just a few seconds but not without coughing out blood.We rushed her to the emergency room, where she received treatment and was there for 2 nights.I have noticed so many other complaints about this product.Please explain to me why is no action being taken.What must it take for the fda to do a mass call back of these alarm.Malem alarms are not safe.I expect the fda to take action after what happened to my daughter.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6743775
• MDR Text Key: 81153780
• Report Number: MW5071242
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/24/2017

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?: Yes
• Device Operator: No Information
• Device Lot Number: NONE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 31 YR