MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT50CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	328724301966
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
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
The strings falls off [device breakage].Case narrative: consumer reported via phone that the tampon strings fall off.No injury was reported.
Event or Problem Description
The strings falls off [device breakage].Case narrative: consumer reported via phone that the tampon strings fall off.No injury was reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT50CT
• 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: 19404998
• Report Number: 1219109-2024-00155
• Device Sequence Number: 6776630
• Product Code: HEB
• UDI-Device Identifier: 00073010711358
• UDI-Public: (01)00073010711358
• 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
• Report Date (Section B): 06/10/2024

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: 328724301966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 36 YR
• Patient Sex: Female