MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAX PEARL TAMPON, REGULAR UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Swelling (2091); Burning Sensation (2146); Cramp(s) (2193); Anaphylactoid (2218); Urticaria (2278); Malaise (2359); Reaction (2414); Shaking/Tremors (2515)

Event Date 12/19/2014

Event Type  Injury  

Event Description

Anaphylactic reaction/severe systemic reaction [anaphylactic reaction].Allergic reaction [hypersensitivity].Hives all over body, urticaria unspecified; hive bumps [urticaria].Cramping -groin [muscle spasm].Cramping - vagina [vulvovaginal pain].Nausea [nausea].Selling - groin [skin swelling].Eyes swelled up [eye swelling].Swelling to eyelids [eyelids oedema] ears swelled up [ear swelling].Edema [oedema] vagina red [vulvovaginal erythema].Cramp in uterus [uterine spasm].Angioedema [angioedema].Everything down there swelling - genital area female [genital swelling].Everything lit up on fire down there - genital area female [ genital burning sensation].Trembling [tremor].Doesn't feel well [malaise].Case description: a mother reported that her adult daughter, age unspecified, used tampax pear tampon, regular scent unknown, 1 tampon from a new box before going to bed on (b)(6) 2014, and she immediately experienced vaginal redness, as well as cramps in her groin and vagina, after inserting the tampon.She then developed hives over her entire body, had nausea, and her eyes, eyelids, groin and ears became swollen, she went to the emergency room that night, and the doctor said she had a severe systematic reaction.Her daughter was diagnosed with an allergic reaction, hives, edema, and anaphylactic reaction.She was treated with oral tylenol, unspecified intravenous fluids, intravenous benadryl, and an unspecified intravenous steroid.The emergency room doctor was unsure if the reaction was related to tampon usage, so she was referred to an allergist and told to follow-up with her health care provider.She was prescribed benadryl, prednisone caplets 12 day dosage, and famotidine for a 7 day dosage.Her symptoms recovered that same night except for the hives which recovered the morning of (b)(6) 2014, and swelling to her eyelids and ears is still present.The case outcome was improved.Her daughter had been using tampax pearl tampon regularly 3 or 4 per day for 4 or 5 hours each time, but has now discontinued using the product.There was no recommendation from the emergency room doctor to discontinue tampon use, so she is currently using a tampon from another box.Relevant history included; allergy: none.No further information was provided.(b)(6) 2015 review of audiolog of initial phone call from the consumer's mother to consumer relations on (b)(6) 2014 revealed the following updates: the mother reported that the consumer age (b)(6) , and she did not feel well enough to report the incident herself.She stated that the genital area "lit up like fire" and was swelling, and she experienced trembling with the nausea.Swelling occurred instantaneously after the consumer removed on tampon and inserted the tampon from the new box.She additionally referred to the hives as "bumps".The consumer spent 3 hours in the emergency room.Dosages of prescribed medication were prednisone 10 mg and famotidine 20 mg.She was given discharge references for hives, angioedema, and anaphylactic reactions.She does not have a history of asthma, hay fever, or eczema.No further information was provided.(b)(6) 2014 follow-up with consumer's mother revealed that the symptoms remain the same, and her daughter is 'up and about' and currently at work.The case outcome was improved.No further information was provided.(b)(6) 2015 received adverse event follow-up questionnaire from the consumer: the consumer, a (b)(6) old female, used the first tampon out of a new box of tampax pearl tampon regular unscented on (b)(6) 2014 and after 10 minutes she experienced symptoms.The consumer reported an additional adverse vent of a cramp in the uterus, and treatment with ibuprofen on (b)(6) 2014.She followed her prescribed treatment of prednisone for 12 days.Relevant history: previous use of product: ye-used once a month since 2005 without problems; allergy, non; concomitant products: none.The case outcome was recovered.No further information was provided.(b)(6) 2015 received hospital emergency department patient discharge instructions (incomplete) pages 1 and 2 of 9 pages: the patient visited an emergency department on (b)(6) 2014 with diagnoses of allergic reaction and urticaria unspecified.The patient was to follow up with her regular provider and follow up with an allergies as soon as possible.Discharge references/attachments (not enclosed) for hives, angioedema, and anaphylactic reaction were given.

Manufacturer Narrative

Product returned 14-jan-2015.Investigation in process.

Manufacturer Narrative

Product returned (b)(6) 2015.Investigation completed (b)(6) 2015.

Event Description

Anaphylactic reaction/ severe systemic reaction [anaphylactic reaction]; allergic reaction [hypersensitivity]; hives all over body, urticaria unspecified; hive bumps [urticaria]; cramping - groin [muscle spasms]; cramping - vagina [vulvovaginal pain]; nausea [nausea]; swelling - groin [skin swelling]; eyes swelled up [eye swelling]; swelling to eyelids [eyelid oedema]; ears swelled up [ear swelling]; edema [oedema]; vagina red [vulvovaginal erythema]; cramp in uterus [uterine spasm]; angioedema [angioedema]; everything down there swelling - genital area female [genital swelling]; everything lit up on fire down there - genital area female [genital burning sensation]; trembling [tremor]; doesn't feel well [malaise].Case description: a mother reported that her adult daughter, age unspecified, used tampax pearl tampon, regular scent unknown, 1 tampon from a new box before going to bed on (b)(6) 2014, and she immediately experienced vaginal redness, as well as cramps in her groin and vagina, after inserting the tampon.She then developed hives over her entire body, had nausea, and her eyes, eyelids, groin and ears became swollen.She went to the emergency room that night, and the doctor said she had a severe systemic reaction.Her daughter was diagnosed with an allergic reaction, hives, edema, and anaphylactic reaction.She was treated with oral tylenol, unspecified intravenous fluids, intravenous benadryl, and an unspecified intravenous steroid.The emergency room doctor was unsure if the reaction was related to tampon usage, so she was referred to an allergist and told to follow-up with her health care provider.She was prescribed benadryl, prednisone caplets 12 day dosage, and famotidine for a 7day dosage.Her symptoms recovered that same night except for the hives which recovered the morning of (b)(6) 2014, and swelling to her eyelids and ears is still present.The case outcome was improved.Her daughter had been using tampax pearl tampon regularly, 3 or 4 per day for 4 or 5 hours each time, but has now discontinued using the product.There was no recommendation from the emergency room doctor to discontinue tampon use, so she is currently using a tampon from another box.Relevant history included: allergy: none.No further information was provided.(b)(6) 2015 review of audiolog of initial phone call from the consumer's mother to consumer relations on (b)(6) 2014 revealed the following updates: the mother reported that the consumer is age (b)(6), and she did not feel well enough to report the incident herself.She stated that the genital area 'lit up like fire' and was swelling, and she experienced trembling with the nausea.Swelling occurred instantaneously after the consumer removed one tampon and inserted the tampon from the new box.She additionally referred to the hives as 'bumps.' the consumer spent 3 hours in the emergency room.Dosages of prescribed medication were prednisone 10mg and famotidine 20mg.She was given discharge references for hives, angioedema, and anaphylactic reactions.She does not have a history of asthma, hay fever, or eczema.No further information was provided.(b)(6) 2014 follow-up with consumer's mother revealed that the symptoms remain the same, and her daughter is 'up and about' and currently at work.The case outcome was improved.No further information was provided.(b)(6) 2015 received adverse event follow-up questionnaire from the consumer: the consumer, a (b)(6) female, used the first tampon out of a new box of tampax pearl tampon regular unscented on (b)(6) 2014, and after 10 minutes she experienced symptoms.The consumer reported an additional adverse event of a cramp in the uterus, and treatment with ibuprofen on (b)(6) 2014.She followed her prescribed treatment of prednisone for 12 days.Relevant history: previous use of product: yes-used once a month since 2005 without problems; allergy: none; concomitant products: none.The case outcome was recovered.No further information was provided.(b)(6) 2015 received hospital emergency department patient discharge instructions (incomplete) pages 1 and 2 of 9 pages: the patient visited an emergency department on (b)(6) 2014 with diagnoses of allergic reaction and urticaria unspecified.The patient was to follow-up with her regular provider, and follow-up with an allergist as soon as possible.Discharge references /attachments (not enclosed) for hives, angioedema, and anaphylactic reaction were given.(b)(6) 2015 product investigation results: the consumer returned one pearl multipack 50 ct carton taped closed with lot code 4243243096.There were 29 wrapped pearl regular tampons with lot code 4243243048, 10 wrapped pearl lites tampons with lot code 4242243049, and 10 wrapped pearl super tampons with lot code 4236243063.One of the super tampons was returned in a bag labeled "from new box-problem box." in addition, one wrapped pearl lites tampon was in a plastic bag labeled "old box, ok tampon," this tampon had a lot code of 3138243049.Visual inspection found no product defect.Making and packing records indicated the product was manufactured as intended.Three retain samples from each of the subject lots were visually inspected and no defects were found.The subject product lots were manufactured as intended and no definite root cause could be identified.

• Brand Name: TAMPAX PEARL TAMPON, REGULAR UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn ME 04210
• Manufacturer Contact: regulatory feminine care ; 6110 center hill avenue; winton hill business center; cincinnati, OH 45224
• MDR Report Key: 4546443
• MDR Text Key: 5520451
• Report Number: 1219109-2015-00001
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K01196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,consumer,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 27 YR
• Patient Weight: 57