MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Copper deficiencies [copper deficiency].Case description: a husband reported via social media that his wife of unspecified age used fixodent denture adhesive, form/version unknown on unspecified date.The husband asserted that the fixodent put his wife in the hospital and almost the grave.The husband posted go online and pull up copper deficiencies, it takes years for this to happen.The case outcome was unknown.No further information was provided.

Manufacturer Narrative

Lot number and product were not provided by reporter, therefore, cannot proceed with batch retain testing or product investigation.

• Brand Name: FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-97 828; GM D-97828
• Manufacturer (Section G): PROCTER & GAMBLE MANUFACTURING CO.; 6200 bryan park road; brown summit NC 27214
• Manufacturer Contact: regulatory oral care ; 8700 mason montgomery road; mason, OH 45040
• MDR Report Key: 4952939
• MDR Text Key: 16226567
• Report Number: 1530449-2015-00009
• Device Sequence Number: 1
• Product Code: KOO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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: 06/30/2015
• 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
• Patient Outcome(s): Hospitalization