FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL PLUS SCOPEFLAVORCREAMSCOPE FLAVOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-19 for FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL PLUS SCOPEFLAVORCREAMSCOPE FLAVOR manufactured by Procter & Gamble Manufacturing Co..

Event Text Entries

[18781392] Hard to breathe [dyspnoea]. Allergic reaction [hypersensitivity]. Starting to go into anaphylaxis [anaphylactic reaction]. Lips are blue [cyanosis]. Whole face is swollen [swelling face]. Swelling-mouth [mouth swelling]. Swelling-throat [pharyngeal oedema]. Throat started closing up [throat tightness]. Eyes were runny and watering [lacrimation increased]. Nasal passage swelling [nasal congestion]. Case description: a female consumer, age unspecified, used fixodent plus scope denture adhesive food seal cream fresh, as she just got her dentures a month ago and her dentures were just starting to slip, and she requested a product ingredient list because she thought she was having an allergic reaction. She explained that she is new to the denture experience and used a little bit of the product for the first time yesterday, (b)(6) 2015. When she awoke today, (b)(6) 2015, and after applying a large amount of the fixodent, her whole face from her nasal passages, mouth, and throat were swollen, her throat was starting to close, her lips were blue, and she was having a hard time breathing. Yesterday, her eyes were runny and watering which she initially attributed to her allergies but now she believed she was starting to go in to anaphylaxis and required her epi-pen. The consumer refused to be transferred to a medical professional; she was planning to take her epi-pen and call back to the company at a later time. The case outcome was not recovered/not resolved. Relevant history: allergies: allergic to quite a few things; medical history: new denture wearer as of a month ago, (b)(6) 2015. Concomitant products were unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


[19139481] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1530449-2015-00004
MDR Report Key4855322
Report Source04
Date Received2015-06-19
Date of Report2015-05-22
Date of Event2015-05-22
Date Mfgr Received2015-05-22
Date Added to Maude2015-06-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMGR. REGULATORY ORAL CARE
Manufacturer Street8700 MASON MONTGOMERY ROAD
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal45040
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL PLUS SCOPEFLAVORCREAMSCOPE FLAVOR
Generic NameDENTURE ADHESIVE
Product CodeKOO
Date Received2015-06-19
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPROCTER & GAMBLE MANUFACTURING CO.
Manufacturer AddressBROWN SUMMIT NC US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-19

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