MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX GENTLE GLIDE UNSCENTED TAMPON REGULAR; MENSTRUAL TAMPON, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Toxic Shock Syndrome (2108); Vomiting (2144); Reaction (2414)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Consumer reports she was treated for toxic shock syndrome associated with use of tampons.Consumer states she has used playtex tampons since her menses began.She stated that in (b)(6) 2014 when she contracted the disease, she had staph on her hands that got transferred to the applicator when she was inserting her tampon.She states that the following day she had a high fever and vomiting, followed by a 103 of fever but no sunburn rash.Consumer states she was hospitalized when her body became septic and she developed an allergic reaction to an antibiotic she was given.Consumer reports she was in the intensive care unit for 6 days.

• Brand Name: PLAYTEX GENTLE GLIDE UNSCENTED TAMPON REGULAR
• Type of Device: MENSTRUAL TAMPON, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer Contact: gale lydic ; 185 saulsbury rd; dover, DE 19904 ; 3026786429
• MDR Report Key: 6004417
• MDR Text Key: 56766944
• Report Number: 0002515444-2016-00011
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2016
• Initial Date FDA Received: 10/06/2016
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 18 YR