MAUDE Adverse Event Report: MEDTECH INC. EFFERDENT PLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 11/30/2016

Event Type  Other  

Event Description

I drank an efferdent plus tab dissolved in water thinking it was an alka seltzer tab.Quantity: other: 1 tablet.Frequency: at bedtime.How was it taken or used: oral.Why was the person using the product: accidental ingestion.

• Brand Name: EFFERDENT PLUS
• Type of Device: EFFERDENT PLUS
• Manufacturer (Section D): MEDTECH INC.
• MDR Report Key: 6140806
• MDR Text Key: 61493398
• Report Number: MW5066464
• Device Sequence Number: 1
• Product Code: EFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 61