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

Lot Number 139369

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

It was going down my throat.I know when i drink water.I used to use another one and i would swallow it [accidental device ingestion].It almost makes me throw up [nausea].It just gets stuck up there at the back of my throat [medication stuck in throat].I have to use so many paper towels to get it out of my mouth./the second time i maybe put too much i couldnt get them off [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6)-year-old female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 139369, expiry date 18th august 2022) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), nausea, medication stuck in throat (serious criteria gsk medically significant), wrong technique in device usage process and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat, wrong technique in device usage process and product complaint were unknown and the outcome of the nausea was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to poligrip cushion comfort.The reporter considered the nausea and medication stuck in throat to be related to poligrip cushion comfort.Additional information : adverse event information was received via phone call on 10 june 2020.Consumer reported that "i purchased this poligrip the new one, the cushion and comfort.I cant use this.I tried to return this but because of the covid they wont take anything back and they're usually really good about returns can you send me a coupon or something so i can buy a new one? it almost makes me throw up, when i try to pull my teeth out.I have to use so many paper towels to get it out of my mouth.It just gets stuck up there at the back of my throat.If you cant help me, i just need to know.I used it two times, the first time it wasn't so bad.The second time, oh my goodness.I'm a sensitive person and it make me.I used the one with the green on the outside, its the only one i can use.Thru out the day, its the only one that i can use.I even tried the fixodent but it doesn't hold.Before the day is over i have to take them out and wash them because they will just fly out my mouth if i don't put more in.They weren't made right.The lot 139369 expiry date 18 august 2022.I just bought last month.I used it that day and then the next day.It did the first time, but maybe i didn't put enough.The second time i maybe put too much i couldn't get them off, the top part.When i went to go take them off, i a heck of the time getting them down, and it was stuck up there.I tried a soft toothbrush, i tried the cloth, you know.I had to use so many paper towels, it was going down my throat.I know when i drink water, i know it goes up there, maybe making them loose thru the day.When i use the green one, it comes off no problem, i use a soft brush and it comes off no problem.I used to use another one and i would swallow it so i changed my strategy.So i tried that with this one, but it didn't work.I didn't want to have to go thru all of that everyday, so i thought i would just try to return it".

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 63-year-old female patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 139369, expiry date 18th august 2022) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On an unknown date, the patient started poligrip cushion comfort.On an unknown date, an unknown time after starting poligrip cushion comfort, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), nausea, medication stuck in throat (serious criteria gsk medically significant), wrong technique in device usage process and product complaint.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat, wrong technique in device usage process and product complaint were unknown and the outcome of the nausea was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to poligrip cushion comfort.The reporter considered the nausea and medication stuck in throat 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 phone call on 10 june 2020.Consumer reported that "i purchased this poligrip the new one, the cushion and comfort.I cant use this.I tried to return this but because of the covid they wont take anything back and they're usually really good about returns can you send me a coupon or something so i can buy a new one? it almost makes me throw up, when i try to pull my teeth out.I have to use so many paper towels to get it out of my mouth.It just gets stuck up there at the back of my throat.If you cant help me, i just need to know.I used it two times, the first time it wasn't so bad.The second time, oh my goodness.I'm a sensitive person and it make me.I used the one with the green on the outside, its the only one i can use.Thru out the day, its the only one that i can use.I even tried the fixodent but it doesn't hold.Before the day is over i have to take them out and wash them because they will just fly out my mouth if i don't put more in.They weren't made right.The lot 139369 expiry date 18 august 2022.I just bought last month.I used it that day and then the next day.It did the first time, but maybe i didn't put enough.The second time i maybe put too much i couldn't get them off, the top part.When i went to go take them off, i a heck of the time getting them down, and it was stuck up there.I tried a soft toothbrush, i tried the cloth, you know.I had to use so many paper towels, it was going down my throat.I know when i drink water, i know it goes up there, maybe making them loose thru the day.When i use the green one, it comes off no problem, i use a soft brush and it comes off no problem.I used to use another one and i would swallow it so i changed my strategy.So i tried that with this one, but it didn't work.I didn't want to have to go thru all of that everyday, so i thought i would just try to return it".Follow up information was received on 24 june 2020 from quality assurance (qa) department regarding complaint (b)(6) for lot number 139369.The investigation reports concluded that, complaint sample not received at investigation site.The batch documentation of complaint samples was checked and no deviations found which could have negative impact to adhesive strength.No further investigation possible.As such complaint was closed as unsubstantiated.

• Brand Name: POLIGRIP CUSHION COMFORT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH; oberkirch baden, wurttemberg ; GM
• MDR Report Key: 10168174
• MDR Text Key: 199067415
• Report Number: 3003341442-2020-00016
• 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
• 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: 08/18/2022
• Device Lot Number: 139369
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Age: 63 YR