MAUDE Adverse Event Report: GLAXOSMITHKLINE POLIGRIP FLAVOUR FREE; DENTURE ADHESIVE

Lot Number JP2C

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

3003721-2019-00218 is associated with argus case (b)(4) poligrip flavour free denture adhesive cream.

Event Description

Allergies [multiple allergies], asthma attacks [asthmatic attack].Must swallow particles of it [accidental device ingestion].Sandy consistency [device physical property issue].Case description: this case was reported by a consumer via call center representative and described the occurrence of multiple allergies in a female patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number jp2c, expiry date 30th september 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started poligrip flavour free.On an unknown date, an unknown time after starting poligrip flavour free, the patient experienced multiple allergies, asthmatic attack, accidental device ingestion (serious criteria gsk medically significant), device physical property issue and product complaint.The action taken with poligrip flavour free was unknown.On an unknown date, the outcome of the multiple allergies, asthmatic attack and accidental device ingestion were resolved with sequelae and the outcome of the device physical property issue and product complaint were unknown.It was unknown if the reporter considered the multiple allergies, asthmatic attack, accidental device ingestion and device physical property issue to be related to poligrip flavour free.Additional details, consumer was calling about poligrip flavor free 40 g.Something was wrong.Consumer started used it last (b)(6).It was causing allergies , asthma attacks and only chemical and dust given me asthma attacks.Consumer must swallow particles of it.Consumer was used it to hold my loose crown.It lasts only about an hour and consumer have to use more.It becomes like chewing gum , it was not holding my crown.Consumer was a refund for it.Consumer have 3 tubes left and kept all the boxes about 15 of them.The product worked at the beginning last (b)(6), but must have changed something, even the consistency had changed it had a sandy consistency.Consumer was over 60 year old.

Manufacturer Narrative

3003721894-2019-00218 is associated with argus case (b)(4) poligrip flavour free denture adhesive cream.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of multiple allergies in a female patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number jp2c, expiry date 30th september 2021) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started poligrip flavour free.On an unknown date, an unknown time after starting poligrip flavour free, the patient experienced multiple allergies, asthmatic attack, accidental device ingestion (serious criteria gsk medically significant), device physical property issue and product complaint.The action taken with poligrip flavour free was unknown.On an unknown date, the outcome of the multiple allergies, asthmatic attack and accidental device ingestion were resolved with sequelae and the outcome of the device physical property issue and product complaint were unknown.It was unknown if the reporter considered the multiple allergies, asthmatic attack, accidental device ingestion and device physical property issue to be related to poligrip flavour free.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, consumer was calling about poligrip flavor free 40 g.Something was wrong.Consumer started used it last november.It was causing allergies , asthma attacks and only chemical and dust given me asthma attacks.Consumer must swallow particles of it.Consumer was used it to hold my loose crown.It lasts only about an hour and consumer have to use more.It becomes like chewing gum , it was not holding my crown.Consumer was a refund for it.Consumer have 3 tubes left and kept all the boxes about 15 of them.The product worked at the beginning last november , but must have changed something, even the consistency had changed it had a sandy consistency.Consumer was over 60 year old.This report is being resubmitted to capture corrections.The information was received on 30 jul 2019 and is as follows.Product complaint event deleted from the case, initially product complaint erroneously captured as a event.

• Brand Name: POLIGRIP FLAVOUR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE; dungarvan ltd; dungarvan,; waterford, ; EI
• MDR Report Key: 9197799
• MDR Text Key: 174952705
• Report Number: 3003721894-2019-00218
• 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
• Report Date: 07/30/2019

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: 09/30/2021
• Device Lot Number: JP2C
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other