MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-02-22 for SUPER POLIGRIP COMFORT SEAL STRIPS manufactured by Kyowa Ltd Izumisano Factory.
[100693225]
3004699328-2018-00003 is associated with argus case (b)(4), super poligrip comfort seal strips (lot 15k0106).
Patient Sequence No: 1, Text Type: N, H10
[100693226]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004699328-2018-00003 |
| MDR Report Key | 7289130 |
| Report Source | CONSUMER |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP COMFORT SEAL STRIPS |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2018-02-22 |
| Lot Number | 15K0106 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA LTD IZUMISANO FACTORY |
| Manufacturer Address | IZUMISANO-CITY, OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-22 |