MAUDE Adverse Event Report: SHEFFIELD PHARMACEUTICALS, LLC EQUATE DENTURE ADHESIVE

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Swelling (2091); Vomiting (2144)

Event Date 08/06/2016

Event Type  No Answer Provided  

Event Description

(b)(6) used the equate denture adhesive cream and it caused her to throw up, have nausea and her mouth to swell.She was going to seek medical attention.Repeated attempts to reach her have been unsuccessful.

• Brand Name: EQUATE DENTURE ADHESIVE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): SHEFFIELD PHARMACEUTICALS, LLC; 170 broad st; new london CT 06320
• MDR Report Key: 5897694
• MDR Text Key: 52839924
• Report Number: 1210513-2016-00012
• Device Sequence Number: 1
• Product Code: KOO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 64