MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT DENTURE ADHESIVE CREAM

Device Problem Use of Device Problem (1670)

Patient Problems Edema (1820); Inflammation (1932); Swelling (2091); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident denture adhesive cream.Polident denture adhesive cream is marketed as super poligrip in the us.

Event Description

Laryngeal cancer (suspected whether laryngeal was developed by using the adhesive cream) [laryngeal cancer] swelling on vocal cords [vocal cord edema], inflammation on vocal cords [vocal cord inflammation], misuse in frequency (used the adhesive cream twice a day as his denture) [device used for unapproved schedule], suspected expired device used [expired device used], intentional device misuse [intentional device misuse].Case description: this case was reported by a consumer via call center representative and described the occurrence of laryngeal cancer in a elderly male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unknown, expiry date 2017) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced laryngeal cancer (serious criteria gsk medically significant), vocal cord edema (serious criteria gsk medically significant), vocal cord inflammation, device used for unapproved schedule, expired device used, intentional device misuse and product complaint.On an unknown date, the outcome of the laryngeal cancer was recovering/resolving and the outcome of the vocal cord edema and vocal cord inflammation were not reported and the outcome of the device used for unapproved schedule, expired device used, intentional device misuse and product complaint were unknown.The reporter considered the laryngeal cancer, vocal cord edema and vocal cord inflammation to be possibly related to polident denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule, expired device used and intentional device misuse to be related to polident denture adhesive cream.Additional details: the action taken with polident denture adhesive cream was unknown.The consumer used polident denture adhesive cream unknown on his denture for about 2 years.It was mentioned that the adhesive cream was main product with pink formulation and unknown volume.He was aware that the adhesive cream should be used once a day, but there were occasions he used the adhesive cream twice a day as his denture came unstuck after a mealtime.Recently, he received tester of polident denture adhesive cream (25g) in a dental clinic, but it seemed that it was expired in 2017.He could not be certain because it was not seen well.He used the tester, and he suspected that it was expired as the adhesion was weak.After he used polident denture adhesive cream for about 2 years, he got laryngeal cancer.He said, there was no reason to occur laryngeal cancer, so he suspected whether laryngeal was developed by using the adhesive cream.At the beginning, inflammation and swelling on voice cords occurred, so he took unspecified examination, and laryngeal cancer was resulted.For laryngeal cancer, he took unspecified procedure on voice cords, and he was ongoing to be convalescent.Laryngeal cancer was getting better, but it was not fully recovered.He would take re-examination on july.There was no medicine he was ongoing to take.He requested mi consultation whether there was any case that laryngeal cancer was developed after use of polident denture adhesive cream, and whether he could keep using the adhesive cream in status occurrence of laryngeal cancer.The patient took healthcare professional consultation.

Event Description

Laryngeal cancer (suspected whether laryngeal was developed by using the adhesive cream) [laryngeal cancer].Swelling on vocal cords [vocal cord edema].Inflammation on vocal cords [vocal cord inflammation].Misuse in frequency (used the adhesive cream twice a day as his denture) [device used for unapproved schedule].Suspected expired device used [expired device used].Circumstance or information capable of leading to medication error [circumstance or information capable of leading to device use error].Intentional device misuse [intentional device misuse].Case description: this case was reported by a consumer via call center representative and described the occurrence of laryngeal cancer in a elderly male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unknown, expiry date 2017) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced laryngeal cancer (serious criteria gsk medically significant), vocal cord edema (serious criteria gsk medically significant), vocal cord inflammation, device used for unapproved schedule, expired device used, intentional device misuse and product complaint.On an unknown date, the outcome of the laryngeal cancer was recovering/resolving and the outcome of the vocal cord edema and vocal cord inflammation were not reported and the outcome of the device used for unapproved schedule, expired device used, intentional device misuse and product complaint were unknown.The reporter considered the laryngeal cancer, vocal cord edema and vocal cord inflammation to be possibly related to polident denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule, expired device used and intentional device misuse to be related to polident denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the action taken with polident denture adhesive cream was unknown.The consumer used polident denture adhesive cream unknown on his denture for about 2 years.It was mentioned that the adhesive cream was main product with pink formulation and unknown volume.He was aware that the adhesive cream should be used once a day, but there were occasions he used the adhesive cream twice a day as his denture came unstuck after a mealtime.Recently, he received tester of polident denture adhesive cream (25g) in a dental clinic, but it seemed that it was expired in 2017.He could not be certain because it was not seen well.He used the tester, and he suspected that it was expired as the adhesion was weak.After he used polident denture adhesive cream for about 2 years, he got laryngeal cancer.He said, there was no reason to occur laryngeal cancer, so he suspected whether laryngeal was developed by using the adhesive cream.At the beginning, inflammation and swelling on voice cords occurred, so he took unspecified examination, and laryngeal cancer was resulted.For laryngeal cancer, he took unspecified procedure on voice cords, and he was ongoing to be convalescent.Laryngeal cancer was getting better, but it was not fully recovered.He would take re-examination on july.There was no medicine he was ongoing to take.He requested mi consultation whether there was any case that laryngeal cancer was developed after use of polident denture adhesive cream, and whether he could keep using the adhesive cream in status occurrence of laryngeal cancer.The patient took healthcare professional consultation.Follow up received for quality assurance department on 13-jul-2018: qa result revealed that product complaint was considered to be unsubstantiated.Follow up information was received via consumer on 17 aug 2018.Polident denture adhesive cream was discontinued (dechallenge was positive).On an unknown date, the outcome of the laryngeal cancer, vocal cord edema and vocal cord inflammation were recovering/resolving and the outcome of the device used for unapproved schedule, expired device used, circumstance or information capable of leading to device use error, intentional device misuse and product complaint were unknown.The reporter considered the laryngeal cancer, vocal cord edema and vocal cord inflammation to be possibly related to polident denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule, expired device used, circumstance or information capable of leading to device use error and intentional device misuse to be related to polident denture adhesive cream.About outcome of adverse event, he was in bad condition, but he got much relieved.He had queried to a dental clinic and a dentist said that there could be no relationship with the adhesive cream and adverse events.From his point of view, however, he did not have concurrent disease and concomitant drug and the point of using the adhesive cream and the development of laryngeal cancer were timely similar, so he queried just in case.He did not answer about permission to healthcare professional contact.He strongly complained that the expiration date should be written as bigger to be read easier because the letter of the expiration date on the adhesive cream was too small to read even though the expiration date was an important information.The causality was assessed by the reporter in initial reporting and the dentist in follow-up reporting, but the most conservative causality assessment was ticked.

Manufacturer Narrative

3003721894-2018-00229 is associated with argus case (b)(4), polident denture adhesive cream.Polident denture adhesive cream is marketed as super poligrip in the us.(b)(6) 2018 product complaint investigation results (issue-7160977): no sample was returned for this complaint and also the batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a batch envelope.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Conclusion: complaint was closed as unsubstantiated.

Manufacturer Narrative

3003721894-2018-00229 is associated with argus case (b)(4), polident denture adhesive cream.Polident denture adhesive cream is marketed as super poligrip in the us.(b)(6) 2018 product complaint investigation results ((b)(4)): no sample was returned for this complaint and also the batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a 'batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Conclusion: complaint was closed as unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of laryngeal cancer in a elderly male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unknown, expiry date 2017) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture adhesive cream.On an unknown date, an unknown time after starting polident denture adhesive cream, the patient experienced laryngeal cancer (serious criteria gsk medically significant), vocal cord edema (serious criteria gsk medically significant), vocal cord inflammation, device used for unapproved schedule, expired device used, intentional device misuse and product complaint.On an unknown date, the outcome of the laryngeal cancer was recovering/resolving and the outcome of the vocal cord edema and vocal cord inflammation were not reported and the outcome of the device used for unapproved schedule, expired device used, intentional device misuse and product complaint were unknown.The reporter considered the laryngeal cancer, vocal cord edema and vocal cord inflammation to be possibly related to polident denture adhesive cream.It was unknown if the reporter considered the device used for unapproved schedule, expired device used and intentional device misuse to be related to polident denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the action taken with polident denture adhesive cream was unknown.The consumer used polident denture adhesive cream unknown on his denture for about 2 years.It was mentioned that the adhesive cream was main product with pink formulation and unknown volume.He was aware that the adhesive cream should be used once a day, but there were occasions he used the adhesive cream twice a day as his denture came unstuck after a mealtime.Recently, he received tester of polident denture adhesive cream (25g) in a dental clinic, but it seemed that it was expired in 2017.He could not be certain because it was not seen well.He used the tester, and he suspected that it was expired as the adhesion was weak.After he used polident denture adhesive cream for about 2 years, he got laryngeal cancer.He said, there was no reason to occur laryngeal cancer, so he suspected whether laryngeal was developed by using the adhesive cream.At the beginning, inflammation and swelling on voice cords occurred, so he took unspecified examination, and laryngeal cancer was resulted.For laryngeal cancer, he took unspecified procedure on voice cords, and he was ongoing to be convalescent.Laryngeal cancer was getting better, but it was not fully recovered.He would take re-examination on july.There was no medicine he was ongoing to take.He requested mi consultation whether there was any case that laryngeal cancer was developed after use of polident denture adhesive cream, and whether he could keep using the adhesive cream in status occurrence of laryngeal cancer.The patient took healthcare professional consultation.Follow up received for quality assurance department on 13-jul-2018: qa result revealed that product complaint was considered to be unsubstantiated.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 7670989
• MDR Text Key: 113534012
• Report Number: 3003721894-2018-00229
• Device Sequence Number: 1
• Product Code: KOT
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other