MAUDE Adverse Event Report: SHEFFIELD PHARMACEUTICALS DOLLAR GENERAL DENTURE ADHESIVE CREAM

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 06/27/2012

Event Type  No Answer Provided  

Event Description

Consumer stated that the dollar general denture adhesive cream she used, caused a burning sensation.She felt faint and like she was going to pass out.It is unk if medical attention was sought.

Manufacturer Narrative

The suspect sample or lot code info was not made available to sheffield pharmaceuticals; therefore, an evaluation of the device was not possible.On 06/28/2012, a self-addressed, stamped envelope was sent to the pt in an attempt to retrieve the device.

• Brand Name: DOLLAR GENERAL DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): SHEFFIELD PHARMACEUTICALS; new london CT 06320
• Manufacturer Contact: 170 broad st.; new london, CT 06320 ; 8604424451
• MDR Report Key: 4540587
• MDR Text Key: 5507926
• Report Number: 1210513-2015-00004
• 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
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1