MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeReg,Super,SuperPlusUnScnt47CT; Tampon, Menstrual, Unscented - HEB

Lot Number	612424303814
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
String just came out in one fluid motion, and i had to go fishing for the cotton - vagina "[foreign body in reproductive tract]" , tried to pull them.Whole string just came out in one fluid motion.Had to go fishing for the cotton "[complication of device removal]" , whole string just came out in one fluid motion - tampon "[device breakage]".Case narrative: consumer stated via phone that whole string came out of tampon in one fluid motion during removal.No serious injury was reported.
Additional Manufacturer Narrative
Product investigation is in progress.

• Brand Name: TampaxTamponsPearlFullSizeReg,Super,SuperPlusUnScnt47CT
• 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: 50154304
• Report Number: 1219109-2026-00198
• Device Sequence Number: 9103871
• Product Code: HEB
• UDI-Device Identifier: 00073010718302
• UDI-Public: (01)00073010718302
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 612424303814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/31/2026
• 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: 45 YR
• Patient Sex: Female