MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPURECOTTONFULLSIZENATURALREGNORUNSCNT24CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 3184243066W23112, 3184243066W2

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Strings started to unravel on tampons, string came completely out of the tampon [device breakage] string was thin and weak.End of the string is stuck to the seal of the wrapper [device physical property issue] case narrative: consumer reported via phone that the tampon strings are thin and unravel.No injury reported.

Manufacturer Narrative

Product investigation is in progress.

Manufacturer Narrative

Product investigation is in progress.

Event Description

String came out when i was trying to remove the tampon [foreign body in reproductive tract].Strings started to unravel on tampons, string came completely out of the tampon [device breakage].String was thin and weak.End of the string is stuck to the seal of the wrapper [device physical property issue].The string came completely out of the tampon when i was trying to remove the tampon.I had to dig the tampon out of vagina [complication of device removal].Case narrative: consumer reported via phone that the tampon strings are thin and unravel.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPURECOTTONFULLSIZENATURALREGNORUNSCNT24CT
• 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: 18905343
• MDR Text Key: 337680814
• Report Number: 1219109-2024-00076
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081555
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3184243066W23112, 3184243066W2
• Was Device Available for Evaluation?: No
• 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