MAUDE Adverse Event Report: HYGINETT HUNGARIAN AMERICAN CO WHISPERPADSINFINITYINFINITYBASEVERWINGREGNORNONDO10CT; PAD, MENSTRUAL, UNSCENTED

Lot Number NOT AVAILABLE

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

There is insufficient information to perform a product investigation.

Event Description

Bartholin cyst [bartholin's cyst], allergic reaction [hypersensitivity], vulva rashes [vulvovaginal rash], pimples vulva [acne], redness vulva [vulvovaginal erythema], vulva swelling [vulvovaginal swelling].A spontaneous report was received via e-mail on 22-dec-2019 from a store stating a consumer, a female of unknown age, used whisper pads infinity base version wing regular-normal non deodorant 10ct on an unspecified date, and experienced an allergic reaction.The outcome was unknown.No further information was provided.23-dec-2019 follow-up with consumer via phone: the consumer reported she began using the whisper pads on the first day of her period which was on (b)(6) 2019.It was the first time she had used this product.She changed the sanitary napkin once every 1 to 2 hours.After using the product for 4 days, her vulva developed rashes, pimples, redness, and swelling.The pimples were as big as her thumb.Her period lasted 5 to 7 days, and product use was discontinued (b)(6) 2019.She sought medical attention on (b)(6) 1 bottle per day.Each day's medical consultation took 1 and a half hours.She reported her condition had not recovered.The outcomes of all adverse events were not recovered/not resolved.The consumer reported she had not experience similar symptoms in the past, and she had always used sanitary napkins from anion.Concomitant product(s): none reported.No further information was provided.06-jan-2020 follow-up with consumer via phone: the consumer reported she was hospitalized on (b)(6) 2019 and discharged around (b)(6) 2019.She had a bartholin's cyst and suturing was required.The sutures were removed, and she was at the hospital every day now.The outcome of bartholin's cyst was unknown.The case outcome remained not recovered/not resolved.No further information was provided.

• Brand Name: WHISPERPADSINFINITYINFINITYBASEVERWINGREGNORNONDO10CT
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): HYGINETT HUNGARIAN AMERICAN CO; hatar u.3; csomor, ; HU
• Manufacturer (Section G): HYGINETT HUNGARIAN AMERICAN CO; hatar u.3; csomor, ; HU
• Manufacturer Contact: regulatory feminine care ; winton hill business center; b6280 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 9671226
• MDR Text Key: 190123160
• Report Number: 1219109-2020-00001
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2019

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention