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

Lot Number 252449

Device Problem Product Quality Problem (1506)

Patient Problem Aspiration/Inhalation (1725)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Aspirate food [food aspiration].Aspirate food, gagging.Applying multiple times a day [gagging].Applying multiple times a day/ he does not use it everyday.[device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of food aspiration in a (b)(6)-year-old male patient who received double salt dental adhesive cream (poligrip cushion comfort) cream (batch number 252449, expiry date 24th october 2022) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On (b)(6) 2020, the patient started poligrip cushion comfort.On (b)(6) 2020, less than a day after starting poligrip cushion comfort, the patient experienced food aspiration (serious criteria gsk medically significant and other: gsk medically significant), gagging, device used for unapproved schedule and product complaint.On an unknown date, the outcome of the food aspiration and gagging were recovering/resolving and the outcome of the device used for unapproved schedule and product complaint were unknown.The reporter considered the food aspiration and gagging to be related to poligrip cushion comfort.It was unknown if the reporter considered the device used for unapproved schedule to be related to poligrip cushion comfort.Additional details, adverse event information was received via call center representative on 21 april 2020.The consumer reported, "i am calling for my husband.My husband only uses poligrip extra care.I convinced him to buy the cushion and comfort.It does not hold.The point is it does not hold and your dentures become loose he was gagging.He does not use it everyday.It was probably about two weeks ago he started.He said it is the worst product he ever used.Product had to be applied multiple times a day.It caused him to aspirate food.He is getting better but it is not fully gone away".Follow up information was received on 11 may 2020 from quality assurance (qa) department regarding complaint number (b)(4) lot number 252449.The investigation report included that, sample was returned for this complaint.The complaint sample was visually inspected and no abnormalities were found.Adhesive strength was within specification for all batches.The batch documentation of complaint samples was checked and no deviation found which could have negative impact to the adhesive strength.Therefore the complaint was considered as unsubstantiated.

• Brand Name: POLIGRIP CUSHION COMFORT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH; oberkirch baden-wurttemberg,; GM
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 10062601
• MDR Text Key: 198492451
• Report Number: 3003341442-2020-00009
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2020

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: No Information
• Device Expiration Date: 10/24/2022
• Device Lot Number: 252449
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR