MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREGNORUNSCNT16CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 1200243038 46

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cervical Changes (1773); Cyst(s) (1800); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pelvic Inflammatory Disease (2000); Abnormal Vaginal Discharge (2123); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Solid Tumour (4552)

Event Type  malfunction  

Manufacturer Narrative

No failure could be identified as a result of the investigation.

Event Description

Vaginitis [vaginal infection] private parts became inflamed [genital tract inflammation] tampon left in private parts [foreign body in reproductive tract] chronic cervicitis [cervicitis] case narrative: consumer reported via phone that she discovered tampon was left in vagina.No serious injury reported.

Event Description

Vaginitis, colpitis [vaginal infection] cystic echo of the left ovary [ovarian cyst] pelvic inflammatory disease [pelvic inflammatory disease] right adnexal mass [adnexa uteri mass] (female) private parts became inflamed [genital tract inflammation] menstrual period usually ends within one week.Later, blood kept appearing inside.Tampon inside caused blood to appear - vaginal [vaginal haemorrhage] tampon left in private parts - female [foreign body in reproductive tract] chronic cervicitis [cervicitis] cervical erosion-like change [cervix disorder] hypogastralgia, abdominal pain [abdominal pain] left adnexa uteri haphalgesia [adnexa uteri pain] stomach painful [abdominal pain upper] hypersecretion of white secretion [vaginal discharge] was not very clean as her menstruation was dripping - tampon [device physical property issue] leukorrhea, smelly- vagina [vaginal odour] case narrative: consumer reported via phone that she discovered tampon was left in vagina.No serious injury reported.14-oct-2022: in a follow-up contact, the consumer indicated that she had stopped using the tampons and she provided medical records.

Manufacturer Narrative

No failure could be identified as a result of the investigation.

• Brand Name: TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREGNORUNSCNT16CT
• Type of Device: 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: 15604267
• MDR Text Key: 307198787
• Report Number: 1219109-2022-00424
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K110669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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
• Device Operator: Lay User/Patient
• Device Lot Number: 1200243038 46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female