MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING CO. FIXODENT DENTURE ADHESIVE, COMPLETE ORIGINAL

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Type  Injury  

Event Description

Tongue swelling (swollen tongue).Face/cheek swelling (swelling face).Case description: a wife reported that her husband, a male age unspecified, recently began using fixodent denture adhesive, complete original cream and reported the following: tongue swelling; face and cheek swelling both symptoms occurring after a couple of weeks of use.The symptom resolved for a week then the tongue swelling returned a second time a short time later.His tongue became very large with the second incident.Her husband took an antihistamine before driving himself to the hosp and emergency room.The hosp stated he should have taken ambulance.Her husband was admitted to the hosp overnight on (b)(6) 2014 as his tongue was so large and the hosp could not figure out what was causing his symptoms.Treatment in the hosp: gave him an epipen and "iv with blood transfusion" to bring the tongue and cheek swelling down.The swelling went down.The wife reported on (b)(6) 2014 her husband used fixodent again and his tongue began to swell again not as much as the previous time.Her husband's tongue and cheek had been swollen overnight.The case outcome was not recovered/not resolved.Past medical history included: medical history - diabetes mellitus.No further info was provided.(b)(6) 2014, (b)(6) f/u phone call: the consumer reported decreased swelling of tongue and face after product use was discontinued.The case outcome was improved.No further info was provided.

Manufacturer Narrative

Product and lot number not provided by the reporter therefore unable to proceed with lot check, batch retain testing or product investigation.Requested consumer return of product.

• Brand Name: FIXODENT DENTURE ADHESIVE, COMPLETE ORIGINAL
• 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 rd; brown summit NC 27214
• Manufacturer Contact: mgr., ra, oral care ; 8700 mason-montgomery rd.; mason business ctr; mason, OH 45040
• MDR Report Key: 3908310
• MDR Text Key: 4671315
• Report Number: 1530449-2014-00003
• 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: Foreign
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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: 05/19/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other