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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE CO. TAMPAX PEARL REGULAR UNSCENTED TAMPONS; TAMPON, MENSTRUAL, UNSCENTED
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PROCTER & GAMBLE CO. TAMPAX PEARL REGULAR UNSCENTED TAMPONS; TAMPON, MENSTRUAL, UNSCENTED Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)
Date of Event 04/03/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Upon using regular tampax pearl developed skin and vaginal irritation, itching, and burning.Initial occurrence in march self-diagnosed as yeast infection day two of period and treated with over counter medicine & cream, quit using product.Over counter cream eased pain but did not clear symptoms in designated time.Second occurrence with same onset of symptoms and timing sought medical care.Yeast infection, uti, and bacterial vaginosis all ruled out via lab tests.Diagnosed as probable allergic reaction to tampons used.
 
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Brand Name
TAMPAX PEARL REGULAR UNSCENTED TAMPONS
Common Device Name
TAMPON, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
PROCTER & GAMBLE CO.
MDR Report Key21814992
Report NumberMW5168794
Device Sequence Number3850543
Product Code HEB
UDI-Device Identifier00073010711358
UDI-Public(01)00073010711358
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 04/04/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/10/2025
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability; Required Intervention;
Patient Age42 YR
Patient SexFemale
Patient Weight77 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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