MAUDE Adverse Event Report: MALEM BED WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Scarring (2061); Blood Loss (2597)

Event Date 10/06/2019

Event Type  Injury  

Event Description

The sensor hurts at night.My son complained several times and i kept assuring him that it's ok till he slept.This was a mistake.Last night, it was the third night of use and the sensor broke while he was asleep.The clip portion (little plastic part) came apart and the wires and metal knives inside were exposed.He likely moved in bed and the metal was so sharp and thin.It cut him severely on his thighs.He was bleeding.There was also a scar on his stomach.I feel bad for forcing him to use the alarm.Very dangerous.Fda safety report id# (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 9172820
• MDR Text Key: 161844999
• Report Number: MW5090309
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR