MAUDE Adverse Event Report: ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH POLIGRIP CUSHION COMFORT; DENTURE ADHESIVE

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Puking of it and blood and skin [vomiting blood].My whole mouth is the size of my fist.A hole as in between my gum and my cheek.I've been in pain for 4 days.It eats away the gum and your cheek and my gums are bleeding.[gingival bleeding].My whole mouth is the size of my fist [swollen mouth].I've been in pain for 4 days / in so much pain [oral pain].There's a big hole like a size of a thumb / a hole as in between my gum and my cheek [gingival disorder].It eats away the gum and your cheek and my gums are bleeding.Puking of it, blood, and skin [peeling gum].A hole as in between my gum and my cheek, there is a big hole like a size of a thumb [aphthous stomatitis].Case description: this case was reported by a consumer via call center representative and described the occurrence of vomiting blood in a female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 170379, expiry date 3rd september 2022) for denture wearer.Concomitant products included no therapy.On (b)(6) 2020, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced vomiting blood (serious criteria gsk medically significant), gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the vomiting blood, gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis were unknown.The reporter considered the vomiting blood, gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis to be related to poligrip cushion comfort.Additional information.Adverse event information was received via call center representative on 10 june 2020.Consumer reported that, "i'm going to sue for this denture cream.My whole mouth is the size of my fist.A hole as in between my gum and my cheek.I have been in pain for 4 days.I'm in so much pain and there a big hole like a size of a thumb.I've been wearing dentures for 6 years now and i'm in so much pain.It eats away the gum and your cheek and my gums are bleeding.Puking of it, blood, and skin.How are you able to get a doctor when it is my mouth.I cannot go yet to the doctor because i'm in and i'm heading back to now.We left on the (b)(6) and started using it on the (b)(6) wedding is on the (b)(6).Last day probably on the (b)(6).My doctor probably seeing on thursday.I probably will just go to urgent care on wednesday.".

Event Description

My gums are bleeding [gingival bleeding], my whole mouth is the size of my fist [swollen mouth], i've been in pain for 4 days / in so much pain [oral pain], skin was being pulled from gum to center of mouth / removing her dentures caused lots of skin to be removed from her gums [torn skin on gum], ripping skin out from my cheeks/a hole as in between my gum and my cheek./there a big hole like a size of a thumb [device induced injury], presents for bilateral maxilla gum pain that occurred after using a new denture suppoft cream/paste.[gum pain], when removing her dentures caused lots of skin to be removed from her gums with bleeding and discomfort [gingival discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of vomiting blood in a female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 170379, expiry date 3rd september 2022) for denture wearer.Concomitant products included no therapy.On (b)(6) 2020, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced vomiting blood (serious criteria gsk medically significant), gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the vomiting blood, gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis were unknown.The reporter considered the vomiting blood, gingival bleeding, swollen mouth, oral pain, gingival disorder, peeling gum and aphthous stomatitis to be related to poligrip cushion comfort.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information.Adverse event information was received via call center representative on 10 june 2020.Consumer reported that, "i'm going to sue for this denture cream.My whole mouth is the size of my fist.A hole as in between my gum and my cheek.I have been in pain for 4 days.I'm in so much pain and there a big hole like a size of a thumb.I've been wearing dentures for 6 years now and i'm in so much pain.It eats away the gum and your cheek and my gums are bleeding.Puking of it, blood, and skin.How are you able to get a doctor when it is my mouth.I cannot go yet to the doctor because i'm in and i'm heading back to now.We left on the 4th and started using it on the 5th wedding is on the 6th.Last day probably on the 9th.My doctor probably seeing on thursday.I probably will just go to urgent care on wednesday." follow up information was received on 15 july 2020 via returned consumer authorization form.Consumer was provided physicians contact information, address details, and provided lot no 170379 and expiry date 03 september 2022 and patient having medical condition liver disorder and kidney tumors.Suspect product name poligrip cushion comfort used for denture adhesive.Product start on (b)(6) 2020 and stated skin was being pulled from gum to center of mouth ripping skin out from my cheeks, gum line and all over my mouth.Took pain relievers and antibiotics.Consumer now not experience any adverse event lasted only for 8 to 9 days but still remains only large open wounds.Holes created by dentures cream turning solid ripped tissue, thumb size holes, flesh skin, flesh or tissue skin stuck to denture cream blood and tissue.On (b)(6) 2020, the patient started poligrip cushion comfort.On (b)(6) 2020 date, an less than a day after starting poligrip cushion comfort, the patient experienced gingival bleeding, swollen mouth, oral pain, torn skin on gum and device induced injury.Poligrip cushion comfort was discontinued on (b)(6) 2020 (dechallenge was positive).On an unknown date, the outcome of the gingival bleeding, swollen mouth, oral pain, torn skin on gum and device induced injury were recovered/resolved and patient demographics details were updated in this case.Treatment drug consider as in this case is unspecified pain relievers and antibiotics drug.Events torn skin on gum, device induced injury and product complaint has been added in the case.This case is associated with product complaint event.Events vomiting blood (serious criteria gsk medically significant), gingival disorder, peeling gum and aphthous stomatitis were removed from the case and seriousness criteria of case has been downgraded to non-serious.Follow up adverse event information was received on 16 july 2020.54 year old female presents for bilateral maxilla gum pain that occurred after using a new denture suppoft cream/paste.Patient was out of town and was unable to obtain her normal denture cream, states that this new cream was pushed into her gums and solidified and when removing her dentures caused lots of skin to be removed from her gums with bleeding and discomfort with material still stuck into her gums unable to be retrieved after removal of dentures.Co-suspect products included erythromycin unknown for product used for unknown indication and tramadol unknown for product used for unknown indication.The patient's past medical history included cervical cancer, degenerative joint disease, hyperlipidemia, scoliosis, transient ischemic attack, neoplasm, colonoscopy, tubal ligation, myelitis and knee operation.Concurrent medical conditions included basal cell carcinoma, generalized rash, bronchitis, chronic back pain, fibromyalgia, gastroesophageal reflux disease, hemorrhoids, hepatitis c, hypoglycemia, renal mass, osteoarthritis, osteoporosis, rectal bleeding, mass, gastric ulcer, tobacco user and latex allergy.Concomitant products included oxycodone + paracetamol (acetaminophen-oxycodone), salbutamol sulphate (albuterol), docusate sodium and no therapy.On an unknown date, the patient started erythromycin at an unknown dose and frequency and tramadol at an unknown dose and frequency.On an unknown time after starting erythromycin, albuterol and docusate sodium, the patient experienced on an unknown date, the patient experienced gum pain, gingival discomfort, multiple allergies and rash.The action taken with erythromycin was unknown.The action taken with tramadol was unknown.On an unknown date, the outcome of the gum pain, gingival discomfort, multiple allergies, rash and product complaint were unknown.The reporter considered the gum pain and gingival discomfort to be related to poligrip cushion comfort.The reporter considered the multiple allergies to be related to erythromycin.Comment: downgrade report.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIGRIP CUSHION COMFORT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH; oberkirc, baden-wurttemberg ; GM
• MDR Report Key: 10232627
• MDR Text Key: 204416014
• Report Number: 3003341442-2020-00017
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): Y
• 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
• Report Date: 06/10/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) ACETAMINOPHEN-OXYCODONE TABLET; 1) NO THERAPY (NO THERAPY); 2) ALBUTEROL (SALBUTAMOL SULPHATE) INHALER; 3) DOCUSATE SODIUM CAPSULE; 4) NO THERAPY
• Patient Outcome(s): Other
• Patient Age: 54 YR