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

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Toxic Shock Syndrome (2108); Distress (2329); Numbness (2415); Ambulation Difficulties (2544)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation in process.Preliminary results indicate quality systems were functioning as intended.The preliminary investigations completed have found no correlation or association between the manufacturing of the sport super+ product at edgewell's dover, delaware plant and the reported tss event.

Event Description

That's why i have toxic shock [toxic shock syndrome].She could not walk [gait inability].The tampon had pieces of cotton missing out of it like it had gotten stuck inside my vagina; i look inside me, there are more [device material issue].They keep getting stuck; i am trying to get it out now [device difficult to use].My vagina hurt [vulvovaginal pain].Her leg was numb [hypoaesthesia].Her stomach was hurting so bad [abdominal pain upper].Attempting to remove what sounded like multiple tampons; inserted yesterday [device use error].Screaming [screaming].Crying [crying].Case narrative: on 19-nov-2021, a spontaneous report was received from a consumer regarding a (b)(6) female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).Medical history and concomitant products were not reported.On an unreported date, the consumer started use of playtex sport plastic, unscented.On (b)(6) 2021, after inserting the product on the night of (b)(6) 2021, the consumer woke up around 4:00 am and attempted to take the product out, only to notice that the tampon had pieces of cotton missing out of it, "like it had gotten stuck inside my vagina." the consumer looked in the toilet, and a piece of the tampon was in the toilet, and then she had to dig into her vagina to get the rest out.Subsequently, on unspecified dates in 2021, the product kept getting stuck, and the consumer's vagina hurt.On an unspecified date in (b)(6) 2021 (reported as (b)(6) 2021 but later refuted), the consumer inserted another tampon.On (b)(6) 2021, she was trying to get "1" out, and it hurt so bad.When she looked "inside me," there were "more inside," and "that's why i have toxic shock." the consumer was screaming and crying, and she "removed 2 more" (interpreted by call specialist as "what sounded like tampons;" unable to further clarify).Additionally, her leg was numb, and her stomach was hurting "so bad." she could not walk.She was in "so much pain." as of (b)(6) 2021, the statuses of product use, pieces of cotton missing out of the tampon, the product getting stuck, toxic shock, and the consumer's vagina hurting were not reported.The outcomes of not being able to walk, her leg being numb, stomach hurting, and screaming and crying were not resolved.No additional information was provided.

• Brand Name: PLAYTEX SPORT PLASTIC, UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 6 research drive; shelton
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 6 research drive; shelton
• MDR Report Key: 13010553
• MDR Text Key: 289688793
• Report Number: 2515444-2021-00021
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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): Other
• Patient Age: 24 YR
• Patient Sex: Female