MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPOCKETRADIANTRADIANTCOMPAKREGNORUNSCNT7CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 3046208001 V3

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

Malfunction hazard product is coming apart, in pieces, shredding, cotton comes out, exposed [device breakage].Case narrative: consumer reported via phone that the cotton is exposed.No injury reported.

Manufacturer Narrative

Product investigation is in progress.

Event Description

Malfunction hazard/product is coming apart, in pieces, shredding.Cotton comes out,exposed device breakage.Case narrative: consumer reported via phone that the cotton is exposed.No injury reported.

Manufacturer Narrative

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

• Brand Name: TAMPAXTAMPONSPOCKETRADIANTRADIANTCOMPAKREGNORUNSCNT7CT
• 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: 18756469
• MDR Text Key: 336088339
• Report Number: 1219109-2024-00063
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K133244
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3046208001 V3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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