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

Lot Number 164379

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I felt the dentures was loose and i could feel the glue go down my throat, i felt it going down, i finally let it go so i can swallow [accidental device ingestion].My throat closed up, and my throat closed up on me [throat constriction].I could not breathe in and i could not breathe out [difficulty breathing].I think i am having an adverse reaction [adverse reaction].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 164379, expiry date unknown) for denture wearer.The patient's past medical history included multiple allergies (i had allergies and asthma) and asthma (i had allergies and asthma).Concurrent medical conditions included gingival recession (my gums have shrunken so much they do not fit well).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 accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), throat constriction, difficulty breathing and adverse reaction.The action taken with poligrip cushion comfort was unknown.On an unknown date, the outcome of the accidental device ingestion, throat constriction, difficulty breathing and adverse reaction were unknown.It was unknown if the reporter considered the accidental device ingestion, throat constriction, difficulty breathing and adverse reaction 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 on 03 march 2020 via call center representative (call).The consumer stated that, "i just used for the first time.It is the cushion and comfort.It says if you have an adverse reaction to call.I think i am having an adverse reaction.I felt the dentures was loose and i could feel the glue go down my throat as i am eating i felt it going down.I just have an upper.My gums have shrunken so much they do not fit well.My throat closed up and i never had this happen before.I went to take a drink a water and my throat closed up on me.I could not breathe in and i could not breathe out.Man was that scary.I finally let go so i can swallow.I had allergies and asthma.I am going to go to the emergency room and get checked out." this report is being resubmitted to capture corrections for the initial information received on 03 march 2020 and is as follows.The event of product complaint was updated into the case.Follow up information was received on 13 march 2020 from department of quality assurance (qa) regarding complaint (b)(4) (product complaint number) for poligrip cushion comfort having lot number 164379.The investigation reports concluded that, complaint stands unsubstantiated.Product sample was not received at the investigation site.There were no deviations during the batch process which could have a negative impact to the adhesive power, the consistency or could explain the above described effect.The results of release of the laboratory for adhesive power and the consistency were all within the specification.Therefore this case was considered to be 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: 9911541
• MDR Text Key: 196757097
• Report Number: 3003341442-2020-00001
• Device Sequence Number: 1
• Product Code: KOL
• 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
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 164379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 76 YR