MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeSuperPlusUnScnt36CT; Tampon, Menstrual, Unscented - HEB

Lot Number	6131243029 69 17:56
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: TampaxTamponsPearlFullSizeSuperPlusUnScnt36CT
• Common Device Name: Tampon, Menstrual, Unscented - HEB
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 50224504
• Report Number: 1219109-2026-00192
• Device Sequence Number: 5545085
• Product Code: HEB
• UDI-Device Identifier: 00073010012172
• UDI-Public: (01)00073010012172
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: 6131243029 69 17:56
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/12/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female