MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREG+SUPERUNSCNT28CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number	4050243012 13 10:04
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Headache (1880); Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.
Event or Problem Description
Retained tampon [foreign body in reproductive tract].Body aches [pain].Headache [headache].Fever [pyrexia].I had a defective tampon [device defective].Case narrative: consumer reported via e-mail that they had a retained tampon.No serious injury reported.
Additional Manufacturer Narrative
Product investigation is in progress.
Event or Problem Description
Retained tampon [foreign body in reproductive tract].Body aches [pain].Headache [headache].Fever [pyrexia].I had a defective tampon [device defective].Case narrative: consumer reported via e-mail that they had a retained tampon.No serious injury reported.
Event or Problem Description
Retained tampon [foreign body in reproductive tract].Body aches [pain].Headache [headache].Fever [pyrexia].I had a defective tampon [device defective].Case narrative: consumer reported via e-mail that they had a retained tampon.No serious injury reported.
Additional Manufacturer Narrative
No failure could be identified as a result of the investigation.

• Brand Name: TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREG+SUPERUNSCNT28CT
• 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: 19360298
• Report Number: 1219109-2024-00149
• Device Sequence Number: 3798408
• Product Code: HEB
• UDI-Device Identifier: 00073010712973
• UDI-Public: (01)00073010712973
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2024

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: 4050243012 13 10:04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/05/2024; 08/09/2024
• 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
• Patient Age: 23 YR
• Patient Sex: Female