MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL BED WETTING ALARM; ALARM CONDITIONED RESPIRONICS ENURESIS

Model Number M048TEC

Device Problems Break (1069); Overheating of Device (1437); Device Inoperable (1663)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/26/2018

Event Type  Injury  

Event Description

My daughter's nighttime wetting alarm has malfunctioned and hurt her.We were fortunate to have detected it early and remove the alarm from her body before it caused any serious damage.The device was warm and she complained of it stinging her.Within a few minutes it was hot and i removed the batteries to prevent any further damage.New device with new batteries has failed to operate safely.

• Brand Name: MALEM MEDICAL BED WETTING ALARM
• Type of Device: ALARM CONDITIONED RESPIRONICS ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7475119
• MDR Text Key: 107092230
• Report Number: MW5076897
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR