MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPOCKETRADIANTRADIANTCOMPAKREGNORUNSCNT28CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	512924301761 21:54
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Malfunction
Event or Problem Description
Fibers are coming off.Leaving some inside as well- vagina [foreign body in reproductive tract].After removing the tampon, there is more fibers [complication of device removal] cramping uterus-pelvic region [dysmenorrhoea].Cramps seems to be worse after applying a new one- tampax [condition aggravated] irritate vulva more and vagina vulva and vaginal [vulvovaginal discomfort] (irritate) after the first day after twelve hours in- tampon [device use issue] (tampon) wrapper pulls up and it's not resealable.Fibers coming off of them - tampax [device breakage].Fibers are coming off.It's leaving some on my body [product residue present].Case narrative: consumer reported via phone that the tampon fibers are coming off and being left inside her body.No serious injury was reported.
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
Fibers are coming off.Leaving some inside as well- vagina [foreign body in reproductive tract].After removing the tampon, there is more fibers [complication of device removal].Cramping uterus-pelvic region [dysmenorrhoea].Cramps seems to be worse after applying a new one- tampax [condition aggravated].Irritate vulva more and vagina vulva and vaginal [vulvovaginal discomfort].(irritate) after the first day after twelve hours in- tampon [device use issue].Fibers coming off of them - tampax [device breakage].Fibers are coming off.It's leaving some on my body [product residue present].Case narrative: consumer reported via phone that the tampon fibers are coming off and being left inside her body.No serious injury was reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.
Event or Problem Description
Fibers are coming off leaving some inside as well- vagina [foreign body in reproductive tract].After removing the tampon, there is more fibers [complication of device removal].Cramping uterus-pelvic region [dysmenorrhoea].Cramps seems to be worse after applying a new one- tampax [condition aggravated].Irritate vulva more and vagina vulva and vaginal [vulvovaginal discomfort].(irritate) after the first day after twelve hours in- tampon [device use issue].Fibers coming off of them - tampax [device breakage].Fibers are coming off.It's leaving some on my body [product residue present].Case narrative: consumer reported via phone that the tampon fibers are coming off and being left inside her body.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPOCKETRADIANTRADIANTCOMPAKREGNORUNSCNT28CT
• 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: 22952977
• Report Number: 1219109-2025-00237
• Device Sequence Number: 8534081
• Product Code: HEB
• UDI-Device Identifier: 00073010713178
• UDI-Public: (01)00073010713178
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K133244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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: 512924301761 21:54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/06/2025; 12/04/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PAD ().; PAD ().; PAD ().
• Patient Age: 23 YR
• Patient Sex: Female