MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE PLAYTEX SPORT PLASTIC, UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Model Number 078300081364

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Local Reaction (2035); 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 [foreign body in reproductive tract].Bacterial vaginosis [bacterial vaginosis].Vaginal odor [vaginal odour].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).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.

• Brand Name: PLAYTEX SPORT PLASTIC, UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• 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: 17878776
• MDR Text Key: 325016303
• Report Number: 2515444-2023-00024
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 078300081364
• Device Lot Number: 23081BA
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Race: White