FDA.reportPublic FDA data

MAUDE MDR 6010460

MDR report key
6010460
Report number
8022168-2016-00003
Event key
0
Event type
3
Date of event
2016-08-01
Date received
2016-10-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MGR. REGULATORY FEMININE CARE
Address
6110 CENTER HILL AVENUE CINCINNATI OH 45224 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALWAYSLNRPAD, MENSTRUAL, UNSCENTEDPROCTER & GAMBLE GMBH & CO. MANUFACTURING OHEHHDNOT AVAILABLER N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-0701. H; 2. O

Event Narratives#

N

Patient 1

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

D

Patient 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.

N

Patient 1

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

D

Patient 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.