MAUDE Adverse Event Report: MALEM MEDICAL ALARM CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 12/04/2017

Event Type  Injury  

Event Description

Five nights ago, our bedwetting alarm exploded and hurt our son.The alarm was barely used for 30 mins when the alarm overheated and batteries leaked out of the alarm.The hot battery acid spilled on my daughter's neck and chest and burnt her severely.We had to rush her to the er and get her treated for burns.This is a brand new alarm that malfunctioned and burnt my daughter.She was discharged and we were told to report this to the fda.

• Brand Name: ALARM CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7107675
• MDR Text Key: 94661065
• Report Number: MW5073895
• 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: 12/09/2017

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?: No
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR
• Patient Weight: 26