MAUDE Adverse Event Report: GLAXOSMITHKLINE LLC POLIDENT DENTU CREME TOOTHPASTE; DENTURE CLEANSER

Lot Number 3J07B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4) polident dentu creme toothpaste.

Event Description

Accidentally used the product to brush her teeth and swallowed the product [accidental device ingestion].Wheezing [wheezing].Feeling of swollen throat [throat swelling].Burned throat [throat burning sensation of].Really hard to breathe [difficulty breathing].Bad reaction [ill-defined disorder].Damaged her throat [adverse event].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme toothpaste) toothpaste (batch number (b)(4), expiry date 31st october 2016) for product used for unknown indication.The patient's past medical history included tonsillectomy.In (b)(6) 2016, the patient started polident dentu creme toothpaste.On an unknown date, an unknown time after starting polident dentu creme toothpaste, the patient experienced accidental device ingestion (serious criteria gsk medically significant), wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and adverse event.The patient was treated with inhaler.Polident dentu creme toothpaste was discontinued (dechallenge was negative).On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and adverse event were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, wheezing, throat swelling, difficulty breathing and adverse event to be related to polident dentu creme toothpaste.The reporter considered the throat burning sensation of and ill-defined disorder to be related to polident dentu creme toothpaste.Additional details, the adverse event information was received on 08 july 2016.Accidental exposure to product was logged because consumer stated she accidentally used the product to brush her teeth and swallowed the product.Adverse event was logged because consumer said she thought she had damaged her throat.Consumer reported that she had wheezing, she felt like her throat was swollen, the product burned her throat and it was really hard for her to breathe, and she had a bad reaction to the product.Consumer stated she started using the product a month ago ((b)(6) 2016) and she experienced all symptoms the same day, last week ((b)(6) 2016) when she accidentally exposed herself to the product.Consumer stopped using the product the same day of the accidentally exposure.Consumer contacted her doctor in regards to her experience with the product.Doctor prescribed an inhaler and a steroid.Doctor stated if her throat had not healed between (b)(6) 2016 consumer should go to the hospital.The treatment drug included steroid.

Event Description

Accidentally used the product to brush her teeth and swallowed the product [accidental device ingestion], wheezing [wheezing], feeling of swollen throat [throat swelling], burned throat [throat burning sensation of], really hard to breathe [difficulty breathing], bad reaction [ill-defined disorder], damaged throat [pharyngeal disorder], case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme toothpaste) toothpaste (batch number 3j07b, expiry date 31st october 2016) for product used for unknown indication.The patient's past medical history included tonsillectomy.In (b)(6) 2016, the patient started polident dentu creme toothpaste.On an unknown date, an unknown time after starting polident dentu creme toothpaste, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder, pharyngeal disorder and laryngeal disorder.The patient was treated with inhaler.On an unknown date, the outcome of the accidental device ingestion and laryngeal disorder were unknown and the outcome of the wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and pharyngeal disorder were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and pharyngeal disorder to be related to polident dentu creme toothpaste.The reporter considered the laryngeal disorder to be unrelated to polident dentu creme toothpaste.Additional details, the adverse event information was received on 08 july 2016.Accidental exposure to product was logged because consumer stated she accidentally used the product to brush her teeth and swallowed the product.Adverse event was logged because consumer said she thought she had damaged her throat.Consumer reported that she had wheezing, she felt like her throat was swollen, the product burned her throat and it was really hard for her to breathe, and she had a bad reaction to the product.Consumer stated she started using the product a month ago ((b)(6) 2016) and she experienced all symptoms the same day, last week ((b)(6) 2016) when she accidentally exposed herself to the product.Consumer stopped using the product the same day of the accidentally exposure.Consumer contacted her doctor in regards to her experience with the product.Doctor prescribed an inhaler and a steroid.Doctor stated if her throat had not healed between (b)(6) 2016 consumer should go to the hospital.The treatment drug included steroid.Follow up information was received on 10 august 2016 via returned consumer authorization form.The consumer returned authorization form with the contact details of physician.The consumer reported that, she thought it was a denture cleanser.Did not need it turned out.The doctor at hospital did a camera down her throat.She had pallets on her voice box.They plan to remove soon.She thought it by her own that was not the product, it was not dentu.The adverse event (for reported event verbatim damaged throat) was updated to pharyngeal disorder.The event laryngeal disorder was added.For the event laryngeal disorder the onset date and outcome was unknown.The reporter considered laryngeal disorder not to be related to polident dentu creme toothpaste.

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme toothpaste) toothpaste (batch number 3j07b, expiry date 31st october 2016) for product used for unknown indication.The patient's past medical history included tonsillectomy.In (b)(6) 2016, the patient started polident dentu creme toothpaste.On an unknown date, an unknown time after starting polident dentu creme toothpaste, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder, pharyngeal disorder and laryngeal disorder.The patient was treated with inhaler.On an unknown date, the outcome of the accidental device ingestion and laryngeal disorder were unknown and the outcome of the wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and pharyngeal disorder were not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, wheezing, throat swelling, throat burning sensation of, difficulty breathing, ill-defined disorder and pharyngeal disorder to be related to polident dentu creme toothpaste.The reporter considered the laryngeal disorder to be unrelated to polident dentu creme toothpaste.Additional details, the adverse event information was received on 08 july 2016.Accidental exposure to product was logged because consumer stated she accidentally used the product to brush her teeth and swallowed the product.Adverse event was logged because consumer said she thought she had damaged her throat.Consumer reported that she had wheezing, she felt like her throat was swollen, the product burned her throat and it was really hard for her to breathe, and she had a bad reaction to the product.Consumer stated she started using the product a month ago ((b)(6) 2016) and she experienced all symptoms the same day, last week ((b)(6) 2016) when she accidentally exposed herself to the product.Consumer stopped using the product the same day of the accidentally exposure.Consumer contacted her doctor in regards to her experience with the product.Doctor prescribed an inhaler and a steroid.Doctor stated if her throat had not healed between (b)(6) 2016 consumer should go to the hospital.The treatment drug included steroid.Follow up information was received on 10 august 2016 via returned consumer authorization form.The consumer returned authorization form with the contact details of physician.The consumer reported that, she thought it was a denture cleanser.Did not need it turned out.The doctor at hospital did a camera down her throat.She had pallets on her voice box.They plan to remove soon.She thought it by her own that was not the product, it was not dentu.The adverse event (for reported event verbatim damaged throat) was updated to pharyngeal disorder.The event laryngeal disorder was added.For the event laryngeal disorder the onset date and outcome was unknown.The reporter considered laryngeal disorder not to be related to polident dentu creme toothpaste.Follow up information was received on 31 august 2016 via adverse event reporting (aer) form by physician.The physician medically confirmed the previously reported adverse event information and stated that doctor did not prescribe or dispense suspect product to the patient.Doctor was a general surgeon and saw the patient in consultation for a reason not related to any product usage and in adverse event section it was reported that the patient thought her symptoms had something to do with the use of the gsk product, but they did not.

• Brand Name: POLIDENT DENTU CREME TOOTHPASTE
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE LLC; 3169 route 145; east durham NY 12423
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5794947
• MDR Text Key: 49565345
• Report Number: 1314819-2016-00003
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2016

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
• Device Expiration Date: 10/31/2016
• Device Lot Number: 3J07B
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/29/2016; 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR