MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP; DENTURE ADHESIVE

Device Problem Use of Device Problem (1670)

Patient Problems Itching Sensation (1943); Pneumonia (2011); Skin Discoloration (2074); Skin Erosion (2075); Skin Inflammation (2443); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

3003721894-2018-00370 is associated with (b)(4), new poligrip.New poligrip is marketed as super poligrip in the us.

Event Description

Pneumonia [pneumonia], mass [mass], pruritus [itchy skin], skin discolouration [skin discolouration], skin erosion [skin erosion], eczema [eczema], device use error [device use error].Case description: this case was reported by a consumer via call center representative and described the occurrence of pneumonia in a (b)(6) female patient who received double salt dental adhesive cream (new poligrip) cream for denture wearer.Concurrent medical conditions included denture wearer.In (b)(6) 2018, the patient started new poligrip.In 2018, less than a month after starting new poligrip, the patient experienced mass, itchy skin, skin discolouration and skin erosion.On an unknown date, the patient experienced pneumonia (serious criteria gsk medically significant), eczema and device use error.On an unknown date, the outcome of the pneumonia and eczema were recovered/resolved and the outcome of the mass, itchy skin, skin discolouration and skin erosion were not recovered/not resolved and the outcome of the device use error was unknown.It was unknown if the reporter considered the pneumonia, mass, itchy skin, skin discolouration, skin erosion, eczema and device use error to be related to new poligrip.Additional details in (b)(6) 2018, the patient started to use new poligrip (unknown) for her dentures.At the time of this report, the patient was unsure about the details of the product because she did not have it on hand.Around three weeks elapsed from the start of the product, mass appeared on the buttocks.The mass was intensely itchy.After she began to assume that new poligrip might be the cause, she used the adhesive in smaller quantities or applied the adhesive to the dentures only during meals, removed it immediately after meals and then tried to wash the inside of the mouth clean.The patient applied the adhesive again for every meal.Subsequently, the symptom became much milder.However, the skin of the buttocks still remained in a similar state of erosion like burnt and black.The patient was reluctant to visit a medical institution because she would have to show the affected region during a consultation.The patient hoped to stop using the adhesive, but could not eat without it because she was wearing the dentures.The patient checked the other manufacturer's product and found that the similar additives were contained, and thus the patient presumed there would be no distinction between new poligrip and the other manufacturer's product.If so, the patient preferred to use new poligrip because it was easiest to use.When the patient turned (b)(6), there might have been a change in her constitution and she experienced eczema on the entire body after receiving a medicine to treat pneumonia that she suffered.At that time, it required two weeks until the patient recovered from the symptom.No further information is expected.

• Brand Name: NEW POLIGRIP
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7981509
• MDR Text Key: 124313185
• Report Number: 3003721894-2018-00370
• 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
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 10/12/2018
• 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: 70 YR