MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT28CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 3187243053640454

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

String shreds and breaks off - tampon [device breakage].Case narrative: consumer reported via email that the tampon string shreds and breaks off.No injury was reported.

Manufacturer Narrative

Product investigation is in progress.

Manufacturer Narrative

Cause was traced to manufacturing.Action plan is in place.

Event Description

String shreds and breaks off - tampon [device breakage].Cause was traced to manufacturing [manufacturing issue].Case narrative: consumer reported via email that the tampon string shreds and breaks off.No injury was reported.

• Brand Name: TAMPAXTAMPONSRADIANTRADIANTSUPERPLUSUNSCNT28CT
• 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: 17782417
• MDR Text Key: 323852807
• Report Number: 1219109-2023-00312
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K110669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

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
• Device Lot Number: 3187243053640454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2023
• 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