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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The string testing completely out of the tampons upon removal [device physical property issue] case narrative: consumer reported via e-mail that the tampon strings testing completely out of the tampons upon removal.No injury reported.

Manufacturer Narrative

There is insufficient information to perform an investigation.

• Brand Name: TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREG+SUPERUNSCNT28CT
• 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: 17745162
• MDR Text Key: 323396854
• Report Number: 1219109-2023-00295
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2023
• 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 Sex: Female