MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-13 for SUPER POLIGRIP COMFORT SEAL STRIPS manufactured by Kyowa, Ltd..
[72742179]
This report is associated with argus (b)(4), super poligrip comfort seal strips.
Patient Sequence No: 1, Text Type: N, H10
[72742180]
The glue and went down my throat and choked me [accidental device ingestion], the glue and went down my throat and choked me [choking], displeased with this product says all days strong and in stead it came undone [product complaint]. Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number unk, expiry date unknown) for product used for unknown indication. This case was associated with a product complaint. Concomitant products included no therapy. On an unknown date, the patient started super poligrip comfort seal strips. On an unknown date, an unknown time after starting super poligrip comfort seal strips, the patient experienced accidental device ingestion (serious criteria gsk medically significant), choking (serious criteria gsk medically significant) and product complaint. On an unknown date, the outcome of the accidental device ingestion, choking and product complaint were unknown. It was unknown if the reporter considered the accidental device ingestion, choking and product complaint to be related to super poligrip comfort seal strips. Additional details, adverse event information was received via email on 6 april 2017. Consumer reported using super poligrip strips, no lot code was provided. Consumer reported the glue went down his throat and choked him. Consumer also reported that this product said all days strong and in stead it came undone. The action taken with super poligrip comfort seal strips was unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004699328-2017-00003 |
| MDR Report Key | 6490362 |
| Report Source | CONSUMER |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-06 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-13 |
| 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 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| 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 | 2017-04-13 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA, LTD. |
| Manufacturer Address | 4-81, TSURUHARA 4-CHOME IZUMISANO-CITY, 598-0071 JA 598-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-13 |