MAUDE Adverse Event Report: BEDWETTING STORE / MALEM MALEM ULTIMATE BEDWETTING ALARM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Type  Injury  

Event Description

My (b)(6) daughter used malem bedwetting alarm (sku j-m04cn) for 3 days only and is to badly injured that i have to rush her to the emergency room with burns and blood red skin rash around the neck.When we buy the product for children we assume they are tested and approved by agencies like fda.But i am ashamed to know that no such effort has been put by the government agency and such dangerous products are sold in the market that cannot only harm a child but make them scarred for life.My daughter has gone through severe pain for days putting me to shame, when i choose such an inferior product.Such products should be banned from selling and no child should go through what my daughter has.The seller is greedy and needs to be punished.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM
• Manufacturer (Section D): BEDWETTING STORE / MALEM
• MDR Report Key: 6683882
• MDR Text Key: 79038265
• Report Number: MW5070748
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/29/2017

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR