MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL GMBH OB ORGANICS SUPER APPLICATOR, 18CT; MENSTRUAL TAMPON

Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A female consumer, over the age of 18 years, reported that she had been using ob products since the mid 1990's and usually used the ob tampons without the applicators but decided since ob put out a new plant-based applicator, she would give the product a try.She stated that since she used the applicator version of the product, she noticed she was having symptoms of fever, pain, foul odorous discharge and pain upon urination.She stated that she did not use any over the counter products because she has multiple health issues and was going for fertility assistance and did not want to affect that process.She stated that she went to the gynecologist on (b)(6) 2019, the doctor did a vaginal exam and found a triangular shaped, one inch piece of the applicator inside of her which was removed.She did not know if the piece of applicator was discarded.She reported that she was diagnosed with a bacterial vaginal infection and prescribed flagyl.She stated that the doctor said that he believed that the infection will clear up since the piece of plastic was removed.No follow-up with the gynecologist was needed.She stated that she had a fertility treatment after using the tampons so could not fully attribute all her symptoms right away to the tampon usage.The consumer stated that she believes she used the ob applicator tampons for one cycle.She also had gone for a fertility treatment after using the tampons and could not understand how the piece of plastic was missed.She will be going for fertility treatments moving forward and was concerned that the infection will delay her fertility treatments and how this will effect the outcome.The consumer was recovering and declined to provide information regarding her age, health issues, concomitant medications and fertility treatments.The product was discarded and was not available for retrieval.
Event or Problem Description
A female consumer, over the age of 18 years, reported that she had been using ob products since the mid 1990's and usually used the ob tampons without the applicators but decided since ob put out a new plant-based applicator, she would give the product a try.She stated that since she used the applicator version of the product, she noticed she was having symptoms of fever, pain, foul odorous discharge and pain upon urination.She stated that she did not use any over the counter products because she has multiple health issues and was going for fertility assistance and did not want to affect that process.She stated that she went to the gynecologist on (b)(6) 2019, the doctor did a vaginal exam and found a triangular shaped, one inch piece of the applicator inside of her which was removed.She did not know if the piece of applicator was discarded.She reported that she was diagnosed with a bacterial vaginal infection and prescribed flagyl.She stated that the doctor said that he believed that the infection will clear up since the piece of plastic was removed.No follow-up with the gynecologist was needed.She stated that she had a fertility treatment after using the tampons so could not fully attribute all her symptoms right away to the tampon usage.The consumer stated that she believes she used the ob applicator tampons for one cycle.She also had gone for a fertility treatment after using the tampons and could not understand how the piece of plastic was missed.She will be going for fertility treatments moving forward and was concerned that the infection will delay her fertility treatments and how this will effect the outcome.The consumer was recovering and declined to provide information regarding her age, health issues, concomitant medications and fertility treatments.The product was discarded and was not available for retrieval.Additional information received from the consumer on 04/27/2020 included the statement that she had a bacterial infection in her vagina due to a piece of ob wrapper that was caught in the tip of the applicator and too small for her to notice.The consumer was contacted on 05/07/2020 and clarified that it was a piece of the ob wrapper and not a piece of the applicator, as previously reported.
Event or Problem Description
A female consumer, over the age of 18 years, reported that she had been using ob products since the mid 1990's and usually used the ob tampons without the applicators but decided since ob put out a new plant-based applicator, she would give the product a try.She stated that since she used the applicator version of the product, she noticed she was having symptoms of fever, pain, foul odorous discharge and pain upon urination.She stated that she did not use any over the counter products because she has multiple health issues and was going for fertility assistance and did not want to affect that process.She stated that she went to the gynecologist on (b)(6) 2019, the doctor did a vaginal exam and found a triangular shaped, one inch piece of the applicator inside of her which was removed.She did not know if the piece of applicator was discarded.She reported that she was diagnosed with a bacterial vaginal infection and prescribed flagyl.She stated that the doctor said that he believed that the infection will clear up since the piece of plastic was removed.No follow-up with the gynecologist was needed.She stated that she had a fertility treatment after using the tampons so could not fully attribute all her symptoms right away to the tampon usage.The consumer stated that she believes she used the ob applicator tampons for one cycle.She also had gone for a fertility treatment after using the tampons and could not understand how the piece of plastic was missed.She will be going for fertility treatments moving forward and was concerned that the infection will delay her fertility treatments and how this will effect the outcome.The consumer was recovering and declined to provide information regarding her age, health issues, concomitant medications and fertility treatments.The product was discarded and was not available for retrieval.Additional information received from the consumer on 04/27/2020 included the statement that she had a bacterial infection in her vagina due to a piece of ob wrapper that was caught in the tip of the applicator and too small for her to notice.The consumer was contacted on (b)(6) 2020 and clarified that it was a piece of the ob wrapper and not a piece of the applicator, as previously reported.Additional information received on 07/13/2020: as per the medical records, this 39 year old single female consumer was seen on (b)(6) 2019 with chief complaints of vaginal odor for the past month or two.She denied discharge, itching or burning.She was in the process of invitro fertilization (ivf) and had just had a mock embryo transfer on (b)(6) 2019 on day 11.She then had some early menstrual bleeding on day 18 of that cycle, which was unusually early for her.Past medical history included back injury, lupus and ruptured left tubal ectopic pregnancy causing hemoperitoneum (b)(6) 2017.Her sti history was negative, no history of abnormal pap smears, last pap (b)(6) 2015 was normal, hpv result was negative, no contraceptive method and she was sexually active.Past surgical history included back surgery and left salpingectomy.Concomitant medications included sertraline (zoloft) 100 mg tablet by mouth daily, aspirin (bayer) 325 mg tablet by mouth daily and trazodone (desyrel) 50 mg tablet by mouth daily at bedtime.Active problem list included depression, dysmenorrhea, anxiety, endometriosis, infertility and irregular menstrual cycle.As per the physical exam, she appeared well-developed and well-nourished and in no distress.There was no lesion on the right or left labia.There was a foreign body in the vagina.Right and left adnexum did not display tenderness.Cervix did not exhibit discharge.A small plastic piece of tampon wrapper was located and removed with a swab.The remainder of vaginal vault was clear.Bacterial vaginosis / vaginitis panel was positive for gardnerella vaginalis.Trichomonas vaginalis was negative.Assessment / plan: bacterial vaginosis, partial tampon wrapper was removed.As per the doctors note from the consumers annual gyn exam on (b)(6) 2019, she has had infertility problems for some time.She has done two ivf cycles with (b)(6), both of which failed due to non- response.They are planning another protocol with her next attempt.No perimenopausal symptoms, last menstrual period was (b)(6) 2019 (exact date), regular every 28-30 days, negative pap history, no intermenstrual bleeding, spotting, or discharge, no dysmenorrhea, dyspareunia, or pms.Pelvic sonogram showed normal endometrium 5 mm, trilaminar, and a 3 cm simple cyst left ovary, no free fluid and normal uterus.
Event or Problem Description
A female consumer, over the age of 18 years, reported that she had been using ob products since the mid 1990's and usually used the ob tampons without the applicators but decided since ob put out a new plant-based applicator, she would give the product a try.She stated that since she used the applicator version of the product, she noticed she was having symptoms of fever, pain, foul odorous discharge and pain upon urination.She stated that she did not use any over the counter products because she has multiple health issues and was going for fertility assistance and did not want to affect that process.She stated that she went to the gynecologist on (b)(6)2019, the doctor did a vaginal exam and found a triangular shaped, one inch piece of the applicator inside of her which was removed.She did not know if the piece of applicator was discarded.She reported that she was diagnosed with a bacterial vaginal infection and prescribed flagyl.She stated that the doctor said that he believed that the infection will clear up since the piece of plastic was removed.No follow-up with the gynecologist was needed.She stated that she had a fertility treatment after using the tampons so could not fully attribute all her symptoms right away to the tampon usage.The consumer stated that she believes she used the ob applicator tampons for one cycle.She also had gone for a fertility treatment after using the tampons and could not understand how the piece of plastic was missed.She will be going for fertility treatments moving forward and was concerned that the infection will delay her fertility treatments and how this will effect the outcome.The consumer was recovering and declined to provide information regarding her age, health issues, concomitant medications and fertility treatments.The product was discarded and was not available for retrieval.Additional information received from the consumer on 04/27/2020 included the statement that she had a bacterial infection in her vagina due to a piece of ob wrapper that was caught in the tip of the applicator and too small for her to notice.The consumer was contacted on (b)(6)/2020 and clarified that it was a piece of the ob wrapper and not a piece of the applicator, as previously reported.Additional information received on 07/13/2020: as per the medical records, this 39 year old single female consumer was seen on (b)(6)2019 with chief complaints of vaginal odor for the past month or two.She denied discharge, itching or burning.She was in the process of invitro fertilization (ivf) and had just had a mock embryo transfer on (b)(6)2019 on day 11.She then had some early menstrual bleeding on day 18 of that cycle, which was unusually early for her.Past medical history included back injury, lupus and ruptured left tubal ectopic pregnancy causing hemoperitoneum (b)(6)2017.Her sti history was negative, no history of abnormal pap smears, last pap (b)(6)2015 was normal, hpv result was negative, no contraceptive method and she was sexually active.Past surgical history included back surgery and left salpingectomy.Concomitant medications included sertraline (zoloft) 100 mg tablet by mouth daily, aspirin (bayer) 325 mg tablet by mouth daily and trazodone (desyrel) 50 mg tablet by mouth daily at bedtime.Active problem list included depression, dysmenorrhea, anxiety, endometriosis, infertility and irregular menstrual cycle.As per the physical exam, she appeared well-developed and well-nourished and in no distress.There was no lesion on the right or left labia.There was a foreign body in the vagina.Right and left adnexum did not display tenderness.Cervix did not exhibit discharge.A small plastic piece of tampon wrapper was located and removed with a swab.The remainder of vaginal vault was clear.Bacterial vaginosis / vaginitis panel was positive for gardnerella vaginalis.Trichomonas vaginalis was negative.Assessment / plan: bacterial vaginosis, partial tampon wrapper was removed.As per the doctors note from the consumers annual gyn exam on (b)(6)2019, she has had infertility problems for some time.She has done two ivf cycles with sgfc, both of which failed due to non- response.They are planning another protocol with her next attempt.No perimenopausal symptoms, last menstrual period was (b)(6)2019 (exact date), regular every 28-30 days, negative pap history, no intermenstrual bleeding, spotting, or discharge, no dysmenorrhea, dyspareunia, or pms.Pelvic sonogram showed normal endometrium 5 mm, trilaminar, and a 3 cm simple cyst left ovary, no free fluid and normal uterus.11/12/2020: follow up to correct the product count from 24 count to 18 count.

• Brand Name: OB ORGANICS SUPER APPLICATOR, 18CT
• Common Device Name: MENSTRUAL TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 02692 ; GM 02692
• MDR Report Key: 9147669
• Report Number: 2515444-2019-00006
• Device Sequence Number: 2664861
• Product Code: HEB
• UDI-Device Identifier: 00078300029939
• UDI-Public: 078300029939
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2020

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 04/27/2020; 07/13/2020; 07/13/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 05/15/2020; 08/05/2020; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ASPIRIN; SERTRALINE; SERTRALINE; TRAZODONE; TRAZODONE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 56