MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING CO. FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333); Injury (2348)

Event Type  Injury  

Event Description

Profound and permanent neurological injuries [nervous system disorder].Severe and permanent physical injuries [injury].Hypocupremia, copper deficiency [copper deficiency].Hyperzincemia [hyperzincaemia].Myeloneuropathy [myelopathy].Zinc poisoning [metal poisoning].Case description: an attorney reported that their female client, currently age (b)(6) years, used fixodent denture adhesive, form/version unknown, unspecified total daily use, as intended to hold dentures that she received approximately 28 years ago, and reported the following: hypocupremia, hyperzincemia, zinc poisoning, copper deficiency and myeloneuropathy, profound and permanent neurological injuries, severe and permanent physical injuries, and other injuries which have left her unable to perform her normal, customary and daily activities.Treatment: has received and will continue to receive unspecified medical care.The case outcome was not recovered/not resolved.Past medical history included: medical history - received dentures approximately 28 years ago.No further information was provided.

Manufacturer Narrative

Lot number or product was not provided by the reporter and case concerns long-term product use.

• Brand Name: FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN
• Type of Device: DENTURE ADHESIVE
• 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: 4856937
• MDR Text Key: 5874300
• Report Number: 1530449-2015-00007
• 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: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• 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: 05/22/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR