MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. TAMPON; TAMPON, MENSTRUAL, SCENTED, DEODORIZED

Model Number SPORT

Device Problems Degraded (1153); Entrapment of Device (1212)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2021

Event Type  Injury  

Event Description

Infection caused by (b)(6) tampon piece left undetectable and rotting in vagina.Fda safety report id# (b)(4).

• Brand Name: TAMPON
• Type of Device: TAMPON, MENSTRUAL, SCENTED, DEODORIZED
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.
• MDR Report Key: 12751053
• MDR Text Key: 280454233
• Report Number: MW5105121
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPORT
• Was Device Available for Evaluation?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White