MAUDE Adverse Event Report: MEDTECH PRODUCTS, INC. EFFERDENT DENTURE CLEANSER POWER CLEAN CRYSTALS

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Caller called to report difficulty opening the package for her denture cleanser.Once she got the package opened she inhaled the contents; ¿there is no way of opening it without breathing it in.¿ reporter called the efferdent consumer line requesting to know what ingredients are in the cleanser she was told ¿they do not have to put the ingredients on the package.¿ reporter states that she does not know what she has inhaled and that she has to call poison control.

• Brand Name: EFFERDENT DENTURE CLEANSER POWER CLEAN CRYSTALS
• Type of Device: EFFERDENT DENTURE CLEANSER POWER CLEAN CRYSTALS
• Manufacturer (Section D): MEDTECH PRODUCTS, INC.
• MDR Report Key: 8386067
• MDR Text Key: 137745191
• Report Number: MW5084578
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/01/2019

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: 03/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other