MAUDE Adverse Event Report: ESSITY HMS NORTH AMERICA INC. PLAYTEX SPORT MULTIPACK SUPER / SUPER PLUS UNSCENTED 32 COUNT; TAMPON, HEB

Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter mentioned that when she applied tampon in the morning, application felt a slight discomfort but she didnt investigate the cause.Three (3) hours later she went to remove the tampon and a shard of the applicator also came out into the toilet.She thought it was her own fault and didnt think anything about it after.Later when she applied new tampon and the same thing happened, but the shard landed in her hand this time.

• Brand Name: PLAYTEX SPORT MULTIPACK SUPER / SUPER PLUS UNSCENTED 32 COUNT
• Common Device Name: TAMPON, HEB
• Manufacturer (Section D): ESSITY HMS NORTH AMERICA INC.; 804 walker rd dover; dover DE 19904
• Manufacturer Contact: vicki heath ; 804 walker rd; dover, DE 19904
• MDR Report Key: 25495399
• Report Number: 2515444-2026-70035
• Device Sequence Number: 10013397
• Product Code: HEB
• UDI-Device Identifier: 00078300135180
• UDI-Public: 00078300135180
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132819
• 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): 06/13/2026

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?: No
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female