MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING CO. FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR; ADHESIVE, DENTURE

Device Problem Insufficient Information (3190)

Patient Problems Neuropathy (1983); Pain (1994); Tingling (2171); Complaint, Ill-Defined (2331); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Product was not provided by the reporter and case concerns long term product use.

Event Description

Muscle deterioration [muscle atrophy], neuropathy [neuropathy peripheral], tingling - both feet and hands [paraesthesia], numbness - both feet [hypoaesthesia], pain [pain].Case description: the consumer, a (b)(6) old male, was using fixodent adhesive original cream no flavor, once a day for 12 years.He was diagnosed with neuropathy 12 years ago.He reported the additional symptoms beginning 12 years ago: muscle deterioration, tingling in hands and both feet, numbness in both feet, and pain.Treatment: unspecified pain medication.He was tested for diabetes and was considered to be pre-diabetic.He stated that the neuropathy had taken over his life.The consumer was on disability.He was concerned that his symptoms were caused by zinc in the fixodent.It was planned to have his blood zinc level tested.He stopped using the product on (b)(6) 2016.The case outcome was not recovered/not resolved.Allergies: none.No further information was provided.

• Brand Name: FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR
• Type of Device: ADHESIVE, DENTURE
• Manufacturer (Section D): PROCTER & GAMBLE MANUFACTURING CO.; 6200 bryan park road; brown summit NC 27214
• 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: 5717960
• MDR Text Key: 47163712
• Report Number: 1530449-2016-00005
• Device Sequence Number: 1
• Product Code: KOO
• Combination Product (y/n): N
• PMA/PMN Number: K945200
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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
• Date Manufacturer Received: 05/13/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 53 YR