MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number MO4SECB

Device Problems Burst Container or Vessel (1074); Melted (1385)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/06/2018

Event Type  Injury  

Event Description

I am a pediatrician and i purchased a malem bedwetting alarm for my son.The bedwetting alarm exploded at night while in use.My son was hurt from the burns and the hot melting batteries.I administered first aid for my son.His burns were first degree burns and i expect him to take between 7-11 days to fully recover from the scars.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL; nottingham, gb ; UK
• MDR Report Key: 7259248
• MDR Text Key: 99778972
• Report Number: MW5075135
• 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: Physician
• Type of Report: Initial
• Report Date: 02/07/2018

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: Health Professional
• Device Model Number: MO4SECB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 18