MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPURECOTTONFULLSIZENATURALREGNORUNSCNT24CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	3364243006 66 13:45
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
Event or Problem Description
Second box has the same defect [device physical property issue].Case narrative: consumer reported via e-mail that the tampons have a defect.No injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Additional Manufacturer Narrative
Cause was traced to manufacturing.Action plan is in place.
Event or Problem Description
Second box has the same defect [device physical property issue].Case narrative: consumer reported via e-mail that the tampons have a defect.No injury reported.
Additional Manufacturer Narrative
Cause was traced to manufacturing.Action plan is in place.
Event or Problem Description
Second box has the same defect, defect is string detached from tampon [device breakage] probable manufacturing cause [manufacturing issue].Case narrative: consumer reported via e-mail that the tampons have a defect; the string detached from tampon.No injury reported.

• Brand Name: TAMPAXTAMPONSPURECOTTONFULLSIZENATURALREGNORUNSCNT24CT
• 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: 20063802
• Report Number: 1219109-2024-00285
• Device Sequence Number: 7783944
• Product Code: HEB
• UDI-Device Identifier: 00073010716315
• UDI-Public: (01)00073010716315
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K081555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 3364243006 66 13:45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/02/2024; 11/04/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female