MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-03-28 for BIOGLUE SURGICAL ADHESIVE UNKNOWN manufactured by Cryolife, Inc. ? Kennesaw.
[140222257]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[140222258]
According to initial reports, a letter to the editor in the journal of thoracic cardiovascular surgery? Is biologic glue the inexperienced surgeon? S best friend?? ?? A handful of patients with proximal aortic anastomotic pseudoaneurysms resulting from biologic clue used in the initial repair of the ataad. Every patient had severe inflammation and tissue necrosis related to bioglue and extensive adhesions as a result of polytetrafluoroethylene felt.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00015 |
| MDR Report Key | 8461723 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-03-28 |
| Date of Report | 2019-07-18 |
| Date Facility Aware | 2019-03-25 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-03-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGLUE SURGICAL ADHESIVE |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-03-28 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-03-28 |