MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlPocketCompakSuperUnScnt16CT; Tampon, Menstrual, Unscented - HEB

Lot Number	5341243018 64 1723
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
Infections - vaginal "[vaginal infection]"."[tampon]".Broke off.Was left inside my body "[foreign body in reproductive tract]".Messed up my uterus "[uterine disorder]"."[tampon]".Tore/broke off "[device breakage]".Case narrative: consumer reported via phone that the tampons itself tore/broke off.No serious injury was reported.
Event or Problem Description
Infections - vaginal "[vaginal infection]"."[tampon]".Broke off.Was left inside my body "[foreign body in reproductive tract]".Messed up my uterus "[uterine disorder]"."[tampon]".Tore/broke off "[device breakage]".Case narrative: consumer reported via phone that the tampons itself tore/broke off.No serious injury was reported.Follow-up 30-jul-2026: product investigation result: no manufacturing cause was identified based on investigation.No serious injury was reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Additional Manufacturer Narrative
30jul2026 product investigation results: no failure could be identified as a result of the investigation.

• Brand Name: TampaxTamponsPearlPocketCompakSuperUnScnt16CT
• 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: 25854032
• Report Number: 1219109-2026-00178
• Device Sequence Number: 5470788
• Product Code: HEB
• UDI-Device Identifier: 00073010712881
• UDI-Public: (01)00073010712881
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K133244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: 5341243018 64 1723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/24/2026
• 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 Sex: Female