MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT18CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	609124302866 1707
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
Smooth removal layer was left in there.The entire braid came out.I finally got [the tampon] out ¿ vagina [foreign body in reproductive tract].Trying to remove [tampon].Entire braid came out.Was able to retrieve all of the tampon eventually [complication of device removal].The smooth removal layer had also been left in there.Entire braid came out - tampon [device breakage].Case narrative: consumer stated via phone that the entire braid of tampon came out during removal.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT18CT
• 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: 25592249
• Report Number: 1219109-2026-00159
• Device Sequence Number: 5481636
• Product Code: HEB
• UDI-Device Identifier: 00073010004542
• UDI-Public: (01)00073010004542
• 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): 07/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 609124302866 1707
• 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: 06/23/2026
• Supplement Report FDA Received Date: 07/15/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female