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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 08/15/2017

Event Type  Injury  

Event Description

I bought the malem ultimate bedwetting alarm from the bedwetting store.I used to connect it to my toddler ever night to pee train him.To my surprise, one day i found the sensor in his mouth.I was lucky to react quickly and take the sensor out otherwise he would have choked.My baby was hurt and i had to take him to the pediatrician for treatment.This is unacceptable.I request the fda to take action against sellers who sell such substandard products.Someone needs to take responsibility for this and reimburse my fees for the alarm and my visit to the doctor.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): BEDWETTING STORE/MALEM MEDICAL
• MDR Report Key: 6830726
• MDR Text Key: 84106713
• Report Number: MW5071855
• 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: 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 27 YR