MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE PLAYTEX SPORT (SCENTED) TAMPONS WITH ODORSHIELD; TAMPON, MENSTRUAL, SCENTED, DEODORIZED

Model Number 078300082545

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Menstrual Irregularities (1959); Foreign Body In Patient (2687)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis, product risk documentation, review of the dhrs and supporting documentation.No trends were identified for the lots or product.Review of the dhr and supporting documentation showed no evidence of issues present with released product that would have an association with this malfunction of tampon performance.The investigation revealed no issues that would require corrective action for the products manufactured.

Event Description

Some fragment of my tampons stayed in my body and i had to have them medically removed [device breakage] some fragment of my tampons stayed in my body and i had to have them medically removed; 3 small pieces of cloth tampon in small balls were trapped underneath the cervix, tucked back on either side [foreign body in reproductive tract] bacterial vaginosis (vaginal odor, brown discharge, vaginal discharge, subacute vaginitis) [bacterial vaginosis] menses (b)(6) 2023 was late for her [menstruation delayed] case narrative: on 06-sep-2023, a spontaneous report was received from a consumer regarding a 37-year-old white, caucasian female who was being treated with playtex sport (scented) tampons with odorshield (tampon, menstrual, scented, deodorized) and playtex sport plastic, unscented (tampon, menstrual, unscented).On 23-oct-2023, additional information was received from medical records.Medical history and concomitant products were not reported.On an unreported date (reported as had used for years, relative to (b)(6) 2023), the patient started use with playtex sport (scented) tampons with odorshield and playtex sport plastic, unscented.On (b)(6) 2023, after starting the product, the patient noticed 1 loose piece came out and the patient thought that was all.On (b)(6) 2023, during sexual relations, she noticed a bad odor which continued until she went to the gynecologist on (b)(6) 2023.Upon examination, the doctor found two pieces of fiber (also reported as 2 more loose pieces) and medically removed them.A vaginal swab was taken to test for stds (sexually transmitted diseases) and was negative.The patient was diagnosed with bacterial vaginosis and was prescribed metronidazole 0.75% gel as treatment.On (b)(6) 2023, the patient used her last dose of medication and felt she had recovered.The patient used 2 different types of tampons during her period and was unsure what box the used tampon came from, but she was almost sure it was "the regular/super multipack." as of (b)(6) 2023, the status of product use was not reported.No additional information was provided.On (b)(6) 2023, the patient's medical history was updated to include her tubes clamped and pregnancy history (b)(6).Concomitant products included multivitamin with iron at 1 tablet, by mouth 1x/day.On (b)(6) 2023, the patient's menses was later for her, which was usually every 24-26 days.This one was 32 days.She took a urine pregnancy test, which was negative.On (b)(6) 2023, the patient presented to the office with complains of vaginal odor for 10 days, which was worse after intercourse.The patient also noticed a small amount of brown discharge too.It was mostly on toilet tissue when wiping, but had no pain.She never had bv (bacterial vaginosis) before, but from what she read online, this seemed consistent with bv to her.She declined the need for any sti (sexually transmitted infections) panel and her pap in (b)(6) 2023 was normal.She remembered the tampon she removed with her last menses seemed to break off.She didn't think much about it, until the nurse practitioner saw 3 pieces of the tampon trapped underneath her cervix (also reported as 3 small pieces of cloth tampon in small balls trapped underneath the cervix, tucked back on either side).Those pieces were removed with ring forceps intact, and no other pieces were noted on extended exam.The patient was diagnosed with subacute vaginitis in the office and genital cultures were performed.The culture indicated normal vaginal flora, and the gram stain result indicated >25 epithelial cells per low power field, <10 polys per low power field, many gram negative rods, moderate gram positive rods, moderate gram variable rods, and few gram positive cocci in pairs and chains.The smear was indicative of bacterial vaginosis.Additionally, chlamydia urine pcr (polymerase chain reaction), n.Gonorrhoeae rna tma urog, candida species, candida glabrata, and trichomonas vaginalis were not detected.Subsequently, the patient was instructed to use an applicatorful of metronidazole 0.75 % gel into the vagina at bedtime for 5 days.No additional information was provided.

Event Description

Some fragment of my tampons stayed in my body and i had to have them medically removed [device breakage].3 small pieces of cloth tampon in small balls were trapped underneath the cervix, tucked back on either side [foreign body in reproductive tract] bacterial vaginosis (vaginal odor, brown discharge, vaginal discharge, subacute vaginitis) [bacterial vaginosis].Menses (b)(6) 2023 was late for her [menstruation delayed].Case narrative: on (b)(6) 2023, a spontaneous report was received from a consumer regarding a 37-year-old white, caucasian female who was being treated with playtex sport (scented) tampons with odorshield (tampon, menstrual, scented, deodorized) and playtex sport plastic, unscented (tampon, menstrual, unscented).On (b)(6) 2023, additional information was received from medical records.Medical history and concomitant products were not reported.On an unreported date (reported as had used for years, relative to (b)(6) 2023), the patient started use with playtex sport (scented) tampons with odorshield and playtex sport plastic, unscented.On (b)(6) 2023, after starting the product, the patient noticed 1 loose piece came out and the patient thought that was all.On (b)(6) 2023, during sexual relations, she noticed a bad odor which continued until she went to the gynecologist on (b)(6) 2023.Upon examination, the doctor found two pieces of fiber (also reported as 2 more loose pieces) and medically removed them.A vaginal swab was taken to test for stds (sexually transmitted diseases) and was negative.The patient was diagnosed with bacterial vaginosis and was prescribed metronidazole 0.75% gel as treatment.On (b)(6) 2023, the patient used her last dose of medication and felt she had recovered.The patient used 2 different types of tampons during her period and was unsure what box the used tampon came from, but she was almost sure it was "the regular/super multipack." as of (b)(6) 2023, the status of product use was not reported.No additional information was provided.On (b)(6) 2023, the patient's medical history was updated to include her tubes clamped and pregnancy history g4p3013.Concomitant products included multivitamin with iron at 1 tablet, by mouth 1x/day.On (b)(6) 2023, the patient's menses was later for her, which was usually every 24-26 days.This one was 32 days.She took a urine pregnancy test, which was negative.On (b)(6) 2023, the patient presented to the office with complains of vaginal odor for 10 days, which was worse after intercourse.The patient also noticed a small amount of brown discharge too.It was mostly on toilet tissue when wiping, but had no pain.She never had bv (bacterial vaginosis) before, but from what she read online, this seemed consistent with bv to her.She declined the need for any sti (sexually transmitted infections) panel and her pap in (b)(6) 2023 was normal.She remembered the tampon she removed with her last menses seemed to break off.She didn't think much about it, until the nurse practitioner saw 3 pieces of the tampon trapped underneath her cervix (also reported as 3 small pieces of cloth tampon in small balls trapped underneath the cervix, tucked back on either side).Those pieces were removed with ring forceps intact, and no other pieces were noted on extended exam.The patient was diagnosed with subacute vaginitis in the office and genital cultures were performed.The culture indicated normal vaginal flora, and the gram stain result indicated >25 epithelial cells per low power field, <10 polys per low power field, many gram negative rods, moderate gram positive rods, moderate gram variable rods, and few gram positive cocci in pairs and chains.The smear was indicative of bacterial vaginosis.Additionally, chlamydia urine pcr (polymerase chain reaction), n.Gonorrhoeae rna tma urog, candida species, candida glabrata, and trichomonas vaginalis were not detected.Subsequently, the patient was instructed to use an applicatorful of metronidazole 0.75 % gel into the vagina at bedtime for 5 days.No additional information was provided.

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis, product risk documentation, review of the dhrs and supporting documentation.No trends were identified for the lots or product.Review of the dhr and supporting documentation showed no evidence of issues present with released product that would have an association with this malfunction of tampon performance.The investigation revealed no issues that would require corrective action for the products manufactured.

• Brand Name: PLAYTEX SPORT (SCENTED) TAMPONS WITH ODORSHIELD
• Type of Device: TAMPON, MENSTRUAL, SCENTED, DEODORIZED
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 804 walker rd; dover 19904
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 804 walker rd; dover 19904
• MDR Report Key: 18517391
• MDR Text Key: 332915185
• Report Number: 2515444-2024-00002
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 078300082545
• Device Lot Number: 23143CA
• Was Device Available for Evaluation?: No
• 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: A
• Patient Sequence Number: 1
• Treatment: MULTIVITAMINS PLUS IRON ,TABLET; MULTIVITAMINS PLUS IRON ,TABLET
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White