MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-03-18 for BIOGLUE SURGICAL ADHESIVE BG3502-5-G manufactured by Cryolife, Inc..
[139110273]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[139110276]
According to the initial report, [the surgeon] has done redo the patient, who had neuro surgery of spinal tumor at thoracic spine using bg 2ml for dural repair in last (b)(6), due to mass formation of bioglue. Additional information from the operating surgeon relays that on (b)(6) 2018 the patient had a meningioma (intradural extramedullary type) removed from the thoracic spine. The bioglue was applied after the dura was sutured with prolene. The area was dry where the bioglue was applied. The mass was located just over the dura mater. An mri (magnetic resonance imaging) was performed before surgery on (b)(6) 2019 to remove the bioglue mass. The bioglue mass was diagnosed about 3 months after the initial surgery. After the removal of the tumor, the patient felt leg weakness was improving. But the patient feels the leg weakness is becoming worse recently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00010 |
| MDR Report Key | 8429746 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-03-18 |
| Date of Report | 2019-06-07 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2019-03-09 |
| Date Added to Maude | 2019-03-18 |
| 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. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD NW |
| 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 | 2019-03-18 |
| Model Number | BG3502-5-G |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-03-18 |