MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE BEDWETTING ALARM; "ALARM, CONDITIONED RESPONSE ENURESIS"

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Daughter was burnt on her neck by the explosion of the malem bedwetting alarm.The batteries have leaked and seriously burnt my daughter.Her skin is red and she has blisters all over her neck.The alarm has somehow gotten so hot that it just caused the batteries to explode inside and hurt my daughter.It was a brand new enuresis alarm purchased from the manufacturers website.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: "ALARM, CONDITIONED RESPONSE ENURESIS"
• Manufacturer (Section D): MALEM MEDICAL LTD; nottingham, gb ; UK
• MDR Report Key: 7809262
• MDR Text Key: 118123348
• Report Number: MW5079324
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• 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