MAUDE Adverse Event Report: PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE ALWAYSLNR; PAD, MENSTRUAL, UNSCENTED

Lot Number NOT AVAILABLE

Device Problems Nonstandard Device (1420); Device Emits Odor (1425); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems Unspecified Infection (1930); Burning Sensation (2146)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

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.

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

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.

• Brand Name: ALWAYSLNR
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE; p&g strasse 1; d-74564; crailsheim, D-718 0; GM D-7180
• Manufacturer (Section G): PROCTER & GAMBLE GMBH & CO. MANUFACTURING OHE; p&g strasse 1; d-74564; crailsheim, D-718 0; GM D-7180
• Manufacturer Contact: regulatory feminine care ; 6110 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 6010460
• MDR Text Key: 56791217
• Report Number: 8022168-2016-00003
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

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
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other