MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TampaxTamponsPearlFullSizeUltraUnScnt60CT; Pad, Menstrual, Unscented - HHD

Lot Number	609915051T
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
"[tampon]" picked out of the body - vagina "[foreign body in reproductive tract]"."[tampon]" disintegrated upon removal and had to be picked out of the body."[complication of device removal]"."[tampon]" disintegrated "[device breakage]".Case narrative: consumer reported via email that the tampon disintegrated during removal.No serious injury was reported.
Event or Problem Description
"[tampon]".Picked out of the body - vagina "[foreign body in reproductive tract]"."[tampon]" disintegrated.Upon removal and had to be picked out of the body "[complication of device removal]"."[tampon]" disintegrated "[device breakage]".Case narrative: consumer reported via email that the tampon disintegrated during removal.No serious injury was reported.Follow-up 02-sep-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
02-sep-2026: no failure could be identified as a result of the investigation.

• Brand Name: TampaxTamponsPearlFullSizeUltraUnScnt60CT
• Common Device Name: Pad, Menstrual, Unscented - HHD
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 50426757
• Report Number: 1219109-2026-00224
• Device Sequence Number: 18436154
• Product Code: HEB
• UDI-Device Identifier: 00073010718289
• UDI-Public: (01)00073010718289
• 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): 09/15/2026

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: 609915051T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/02/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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 Sex: Female