MAUDE Adverse Event Report: KYOWA LTD IZUMISANO FACTORY SUPER POLIGRIP COMFORT SEAL STRIPS; DENTURE ADHESIVE

Lot Number 19KD109

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

He apparently swallowed one of them while eating last night.It was missing when he took his bottom dentures out last night to soak them lot is either 19kd109 as given or 9k0109 [accidental device ingestion].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) male patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 19kd109, expiry date 10th august 2022) for denture wearer.Concomitant products included no therapy.On (b)(6) 2020, the patient started super poligrip comfort seal strips.On (b)(6) 2020, an unknown time after starting super poligrip comfort seal strips, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant ).The action taken with super poligrip comfort seal strips was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to super poligrip comfort seal strips.Additional information: adverse event information was received via phone on 05 june 2020.Consumer reported that "behalf of my husband its the poligrip strips he swallowed one them, he apparently swallowed one of them while eating last night.It was missing when he took his bottom dentures out last night to soak them.He wants to know if it will hurt him in anyway.Yesterday was his first day.He always used the other one, by somebody else.They broke his fingers out, he had an allergic reaction to the.He said they were very comfortable.He just wanted to know the effects he would be.He seems fine this morning, he does know for sure when he lost it.We have doctor appointments on the 22nd annual check up, he probably will.They should put that on the box so they don't worry that strip may dissolve over time while in use".

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA LTD IZUMISANO FACTORY; izumisano-city, osaka ; JA
• MDR Report Key: 10229495
• MDR Text Key: 203529810
• Report Number: 3004699328-2020-00005
• 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: 06/05/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2022
• Device Lot Number: 19KD109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/03/2020
• 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: 79 YR