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

Lot Number 15K0106

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

3004699328-2018-00003 is associated with argus case (b)(4), super poligrip comfort seal strips (lot 15k0106).

Event Description

Patient swallowed the whole strip [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 57056xc, expiry date unknown) for denture failure.Co-suspect products included polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 15k0106, expiry date unknown) for denture failure.Concomitant products included no therapy.On an unknown date, the patient started super poligrip comfort seal strips and super poligrip comfort seal strips.On an unknown date, an unknown time after starting super poligrip comfort seal strips and super poligrip comfort seal strips, the patient experienced accidental device ingestion (serious criteria gsk medically significant).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 and super poligrip comfort seal strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was received via phone call on (b)(6) 2018.The consumer reported that the patient swallowed the whole strip.Primary package lot number was 57056xc and secondary package lot number was 15k0106.

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA LTD IZUMISANO FACTORY; izumisano-city, osaka ; JA
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7289130
• MDR Text Key: 100693225
• Report Number: 3004699328-2018-00003
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 15K0106
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• 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: 91 YR