MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC PLAYTEX SPORT TAMPONS 36CT. REGULAR UNSCENTED; PLAYTEX SPORT REGULAR UNSCENTED WITH PLASTIC APPLICATOR

Lot Number	20107BB
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Nausea (1970); Complaint, Ill-Defined (2331)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that she was at the end of her menstrual cycle when she inserted a tampon because she was spotting.Consumer stated that she went to remove the tampon that night, did not find the string and thought she had forgotten that she already removed it.Consumer reported that in the following days she continued to experience spotting and had a foul smell.On (b)(6) 2020, four days after the tampon was inserted, she woke up feeling very ill with nausea and cold-like symptoms.She self-checked internally while in shower as she was concerned some of the tampon may have remained inside of her, when she discovered the tampon was still inserted.She was unable to remove the tampon and rushed to the emergency room fearing that she was suffering from toxic shock syndrome (tss).The tampon was removed by medical staff and it was discovered that there was no string attached to the tampon.Consumer stated that blood work (unspecified) done in the er did not show any infection or tss.No medications were prescribed and no follow appointment was required.Consumer stated that she did not notice that the tampon did not have a string prior to insertion.Consumer reported that she has recovered.

• Brand Name: PLAYTEX SPORT TAMPONS 36CT. REGULAR UNSCENTED
• Common Device Name: PLAYTEX SPORT REGULAR UNSCENTED WITH PLASTIC APPLICATOR
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC; 804 walker road; dover DE 19904
• MDR Report Key: 10677340
• Report Number: 2515444-2020-00009
• Device Sequence Number: 3457431
• Product Code: HEB
• UDI-Device Identifier: 00078300099222
• UDI-Public: 078300099222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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
• Device Lot Number: 20107BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR