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

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 06/20/2017

Event Type  Injury  

Event Description

Subject is a (b)(6) year old female with nighttime incontinence.She was prescribed an enuresis alarm for the treatment of primary nocturnal enuresis.The enuresis alarm has caused an adverse effect upon first use.Batteries have leaked out causing possible toxic reaction with child's skin.Alarm case has melted from heat.Alarm was returned to place of purchase.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: BED WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL ; gb ; UK
• MDR Report Key: 6680226
• MDR Text Key: 78911199
• Report Number: MW5070716
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2017
• 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): Life Threatening; Other
• Patient Age: 5 YR
• Patient Weight: 3