BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALWAYSLNR

    MDR report key: 6010460 · Received October 7, 2016

    Report

    Report Number
    8022168-2016-00003
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 25, 2016
    Manufacturer
    PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE
    Product Code
    HHD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    INFECTION IN VAGINAL AREA [VAGINAL INFECTION]. REALLY BURNS-VAGINA AND ALL THE LABIA [VULVOVAGINAL BURNING SENSATION]. ALWAYS LINER HAD FRAGRANCE/PACKAGE DOES NOT INDICATE A SCENT [PRODUCT ODOUR ABNORMAL]. CASE DESCRIPTION: AN ADULT FEMALE CONSUMER REPORTED VIA PHONE ON (B)(6) 2016 USING ALWAYS LINER FOR THE FIRST TIME BEGINNING ON AN UNSPECIFIED DATE, 1 LINER EVERY TWO HOURS (5-6 TIMES A DAY) AND A WEEK AGO GOT A SERIOUS INFECTION IN HER VAGINAL AREA AS WELL AS BURNING TO HER VAGINA AND LABIA. SHE STATED THAT SHE VISITED A GYNECOLOGIST AT A CLINIC WHO RECOMMENDED/PRESCRIBED ANTIBIOTICS, OINTMENTS (AGISTEN) AND SMALL RED PILLS (DOES NOT REMEMBER WHAT IT IS CALLED) BUT HER CONDITION IS GETTING WORSE. SHE REPORTED THAT SHE WAS CURRENTLY ON HER WAY TO THE EMERGENCY ROOM. SHE DESCRIBED THAT SHE ALWAYS USES ALWAYS, BUT EVER SINCE THE NEW SERIES THERE IS A PROBLEM, AND BY MISTAKE SHE BOUGHT ALWAYS WITH FRAGRANCE. PRODUCT USE WAS DISCONTINUED THIS MORNING. RELEVANT HISTORY: ALLERGY TO FRAGRANCES. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON 11-SEP-2016 CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THAT SHE HAS HAD PROBLEMS UP UNTIL NOW, THAT SHE WAS IN THE HOSPITAL AND THE ANTIBIOTIC THEY GAVE HER DID NOT HELP AND SHE EVEN WENT TO A PRIVATE PHYSICIAN. THE CASE OUTCOME REMAINED NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    INFECTION IN VAGINAL AREA [VAGINAL INFECTION]; REALLY BURNS-VAGINA AND ALL THE LABIA [VULVOVAGINAL BURNING SENSATION]; ALWAYS LINER HAD FRAGRANCE/PACKAGE DOES NOT INDICATE A SCENT [PRODUCT ODOUR ABNORMAL]. CASE DESCRIPTION: AN ADULT FEMALE CONSUMER REPORTED VIA PHONE ON (B)(6) 2016 USING (B)(6) LINER FOR THE FIRST TIME BEGINNING ON AN UNSPECIFIED DATE, 1 LINER EVERY TWO HOURS (5-6 TIMES A DAY) AND A WEEK AGO GOT A SERIOUS INFECTION IN HER VAGINAL AREA AS WELL AS BURNING TO HER VAGINA AND LABIA. SHE STATED THAT SHE VISITED A GYNECOLOGIST AT A CLINIC WHO RECOMMENDED/PRESCRIBED ANTIBIOTICS, OINTMENTS (AGISTEN) AND SMALL RED PILLS (DOES NOT REMEMBER WHAT IT IS CALLED) BUT HER CONDITION IS GETTING WORSE. SHE REPORTED THAT SHE WAS CURRENTLY ON HER WAY TO THE EMERGENCY ROOM. SHE DESCRIBED THAT SHE ALWAYS USES (B)(6), BUT EVER SINCE THE NEW SERIES THERE IS A PROBLEM, AND BY MISTAKE SHE BOUGHT ALWAYS WITH FRAGRANCE. PRODUCT USE WAS DISCONTINUED THIS MORNING. RELEVANT HISTORY: ALLERGY TO FRAGRANCES. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2016 CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THAT SHE HAS HAD PROBLEMS UP UNTIL NOW, THAT SHE WAS IN THE HOSPITAL AND THE ANTIBIOTIC THEY GAVE HER DID NOT HELP AND SHE EVEN WENT TO A PRIVATE PHYSICIAN. THE CASE OUTCOME REMAINED NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2016 CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THAT SHE USED (B)(6) PADS SIZE LARGE AND WAS HOSPITALIZED FOR 3 DAYS FOR HER SYMPTOMS AND THINKS THAT SHE RECEIVED ANTIBIOTICS. SHE STATED THAT SHE HAD SYMPTOMS FOR ANOTHER WEEK. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663295 ALWAYSLNR PAD, MENSTRUAL, UNSCENTED HHD PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O