MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeSuperPlusUnScnt50CT; Tampon, Menstrual, Unscented - HEB

Lot Number	611024303069
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	Serious Injury
Event or Problem Description
Staph infection "[staphylococcal infection]" a "[tampon]" piece ripped off inside my vagina ¿ i got some pieces out ¿ and went to the emergency room where they removed the remaining pieces of tampon "[foreign body in reproductive tract]" when i tried to remove "[tampon]", a piece ripped off inside my vagina ¿ it was really hard to get out/hard to expel "[complication of device removal]" tampon was broken and ripped "[device breakage]" case narrative: consumer reported via phone that a "[tampon]" piece ripped off inside her vagina during removal, she got some pieces out and went to the emergency room to have the remaining pieces of the tampon removed.No serious injury was reported.
Event or Problem Description
Staph infection "[staphylococcal infection]".A "[tampon]" piece ripped off inside my vagina ¿ i got some pieces out ¿ and went to the emergency room where they removed the remaining pieces of tampon "[foreign body in reproductive tract]".When i tried to remove "[tampon]", a piece ripped off inside my vagina ¿ it was really hard to get out/hard to expel "[complication of device removal]".Tampon was broken and ripped "[device breakage]".Case narrative: consumer reported via phone that a "[tampon]" piece ripped off inside her vagina during removal, she got some pieces out and went to the emergency room to have the remaining pieces of the tampon removed.No serious injury was reported follow up received on 19-aug-2026: product return was received on (b)(6) 2026.Product investigation results: no failure could be identified as a result of the investigation.No serious injury was reported.
Event or Problem Description
Staph infection "[staphylococcal infection]", acute vaginitis "[vaginal infection]", a "[tampon]" piece ripped off inside my vagina, i got some pieces out, and went to the emergency room where they removed the remaining pieces of tampon "[foreign body in reproductive tract]" when i tried to remove "[tampon]", a piece ripped off inside my vagina, it was really hard to get out/hard to expel "[complication of device removal]", tampon was broken and ripped "[device breakage]".Case narrative: consumer reported via phone that a "[tampon]" piece ripped off inside her vagina during removal, she got some pieces out and went to the emergency room to have the remaining pieces of the tampon removed.No serious injury was reported follow up received on 19-aug-2026: product return was received on 19-aug-2026.Product investigation results: no failure could be identified as a result of the investigation.No serious injury was reported.Follow up received on 10-sep-2026: event, lab tests and medical history were added.No serious injury was reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Additional Manufacturer Narrative
28-aug-2026 : product investigation results: no failure could be identified as a result of the investigation.
Additional Manufacturer Narrative
28-aug-2026: product investigation results: no failure could be identified as a result of the investigation.

• Brand Name: TampaxTamponsPearlFullSizeSuperPlusUnScnt50CT
• 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: 50406444
• Report Number: 1219109-2026-00217
• Device Sequence Number: 10489491
• Product Code: HEB
• UDI-Device Identifier: 00073010711242
• UDI-Public: (01)00073010711242
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 611024303069
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/19/2026; 09/10/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/08/2026; 09/25/2026
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 202 LB