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

Device Problem Insufficient Information (3190)

Event Type  Other  

Event Description

Paralyzed [paralysis].Case description: a consumer reported that their sister, age unspecified, used fixodent denture adhesive, form/version unknown and reported that she is now paralyzed.Medical care and treatment unspecified.The case outcome was not recovered/not resolved.No further information was provided.

Manufacturer Narrative

Lot number or product was not provided by the reporter therefore unable to proceed with batch retain testing or product investigation.

• Brand Name: FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): PROCTER & GAMBLE MANUFACTURING CO.; brown summit NC
• Manufacturer (Section G): PROCTER & GAMBLE MANUFACTURING CO.; 6200 bryan park road; brown summit NC 27214
• Manufacturer Contact: mgr ; 8700 mason-montgomery rd.; mason business center; mason, OH 45040
• MDR Report Key: 3593269
• MDR Text Key: 4033993
• Report Number: 1530449-2014-00001
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• 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: 11/27/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability