MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. PLAYTEX SPORT REGULAR UNSCENTED 36CT; MENSTRUAL TAMPON, PRODUCT CODE: HEB

Lot Number	20008BB
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A female consumer reported that when she tried to remove the tampon the string came out and the tampon did not.Consumer stated that she had to go to urgent care on (b)(6) 2020 to have the tampon removed.No additional information was provided.

• Brand Name: PLAYTEX SPORT REGULAR UNSCENTED 36CT
• Common Device Name: MENSTRUAL TAMPON, PRODUCT CODE: HEB
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker road; dover, de
• MDR Report Key: 10484181
• Report Number: 2515444-2020-00005
• Device Sequence Number: 3154824
• Product Code: HEB
• UDI-Device Identifier: 00078300099222
• UDI-Public: 078300099222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 20008BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/02/2020
• 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: 36 YR