MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. PLAYTEX SPORT; TAMPON, MENSTRUAL, SCENTED, DEODORIZED

Device Problems Device Emits Odor (1425); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2022

Event Type  Injury  

Event Description

I was using playtex sport 360 tampons and during one of my changes a [invalid] from the end had to somehow came off of the tampon and get pushed inside of me by the other tampon, which ultimately led to my body telling me something was wrong by giving off a smell and shortly after so my boyfriend found the [invalid] working its way out of my vaginal canal.This could have lead to toxic shock or even death but thankfully i have only gotten a uti.Dates of use: (b)(6) 2022.

• Brand Name: PLAYTEX SPORT
• Type of Device: TAMPON, MENSTRUAL, SCENTED, DEODORIZED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.
• MDR Report Key: 15485312
• MDR Text Key: 300698142
• Report Number: MW5112260
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ONE A DAY MULTI VITAMINS
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White