MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT18CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 3075 2080 V2 18:58

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product investigation is in progress.

Event Description

Outer layer of the tampon mesh became unattached [device breakage].Case narrative: consumer reported via e-mail that the outer layer of the tampon became unattached during removal.No injury reported.

Event Description

Some of the outer layer of the tampon mesh had become unattached from the main tampon and had become stuck inside of me [foreign body in reproductive tract].Outer layer of the tampon mesh became unattached [device breakage].Case narrative: consumer reported via e-mail that the outer layer of the tampon became unattached during removal.No serious injury reported.

Manufacturer Narrative

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

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT18CT
• 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: 18001824
• MDR Text Key: 326457417
• Report Number: 1219109-2023-00370
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K081555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: 3075 2080 V2 18:58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 23 YR
• Patient Sex: Female