MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-07-06 for COREGA ADHESIVE STRIPS manufactured by Kyowa, Ltd..
[79142595]
This report is associated with (b)(4), corega adhesive strips. Corega adhesive strips are marketed in the us as super poligrip comfort seal adhesive strip.
Patient Sequence No: 1, Text Type: N, H10
[79142596]
Profuse bleeding [hemorrhage]. Case description: this case was reported by a dentist via sales rep and described the occurrence of bleeding in a (b)(6) female patient who received polyethylene oxide, sodium carboxymethylcellulose (corega adhesive strips) strip for product used for unknown indication. On an unknown date, the patient started corega adhesive strips. On an unknown date, an unknown time after starting corega adhesive strips, the patient experienced bleeding (serious criteria gsk medically significant). On an unknown date, the outcome of the bleeding was unknown. It was unknown if the reporter considered the bleeding to be related to corega adhesive strips. Additional details, initial adverse event report was received on 26 jun 2017 through sales representative. The reporter commented that a (b)(6) female patient consumed anticoagulants, she retired her dental prosthesis placed with corega adhesive and the patient had a profuse bleeding. The action taken of corega adhesive strips was unknown. This report was being resubmitted to capture corrections. The information was received on 01 jul 2017 and was as follows: the device type was captured wrong as dermatological device which was changed to denture adhesive. This report was being resubmitted to capture corrections. The information was received on 26 jun 2017 and the information as follows: the previous error correction date 01 jul 2017 (wrong date reported) was updated to 26 jun 2017 (corrected date).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004699328-2017-00009 |
| MDR Report Key | 6689091 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-07-06 |
| Date of Report | 2017-06-26 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-06 |
| 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 | COREGA ADHESIVE STRIPS |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2017-07-06 |
| 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 | 2017-07-06 |