MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Toxic Shock Syndrome (2108); Vomiting (2144); Coma (2417); Loss of consciousness (2418)

Event Date 10/11/2014

Event Type  Injury  

Event Description

Toxic shock syndrome [toxic shock syndrome], vomiting [vomiting], high fever [pyrexia], fell unconscious [ loss of consciousness], fell into a coma[coma].Case description: the mother of a (b)(6)-year old female reported that her daughter used tampax tampon, version/absorbency/scent unk beginning on an unspecified date, and she had toxic shock twice; once in (b)(6) 2014.She now has to live with having toxic shock syndrome.No further info was provided.On (b)(6) 2014: consumer relations f/u phone call with the mother: the mother reported that her daughter first experienced toxic shock syndrome on (b)(6) 2014, and was hospitalized for 1 week in intensive care.The second episode occurred on (b)(6) 2014; she started vomiting, had a high fever, and fel unconscious and into a coma.She was treated with a high dose of intravenous adrenaline, very strong antibiotics, and penicillin.She is better physically, but she is very psychologically affected and will be seeing a psychiatrist.She stated her daughter lives with the syndrome every day.She had used tampax since her first period, but now she is not permitted to use tampons for the rest of her life.The case outcome was improved.No further info was provided.On (b)(6) 2015: f/u phone call with general practitioner: the physician reported that she is awaiting the final opinion of specialists regarding this case.The hosp where the consumer first sought treatment had asked for an additional opinion from another hosp.The consumer had also asked for the opinion of someone in another location.The physician reported that the consumer's daughter had likely used tampons a second time.It was not confirmed whether the tampon was the cause.No further info was provided.

Manufacturer Narrative

Lot number or product was not provided by the reporter.

• Brand Name: TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK
• Type of Device: NI
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; auburn ME
• Manufacturer (Section G): HYGINETT HUNGARIAN AMERICAN CO.; hatar u.3; csomor 2141 ; HU 2141
• Manufacturer Contact: ,mgr ; winton hill business ctr; 6110 center hill ave; cincinnati, OH 45224
• MDR Report Key: 4768489
• MDR Text Key: 20726842
• Report Number: 3004443383-2015-00001
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• 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
• Date Manufacturer Received: 01/23/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 15 YR