MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-04 for BIOGLUE SURGICAL ADHESIVE BG3515-5-G manufactured by Cryolife, Inc. ? Kennesaw.
[122794927]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[122794928]
According to initial reports, bioglue was used to seal the suture line of patch on femoral artery post evar cut down (b)(6) 2018. Patient wound was not healing as expected and showed a severe inflammatory response. On (b)(6) 2018 the wound was reopened; bioglue was identified as the source of inflammation. The bioglue was removed, the wound was sutured closed and subsequently healed. The patient was discharged without further incident. Point of note form surgeon: patient had multiple allergies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00038 |
| MDR Report Key | 7935799 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-04 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-04-19 |
| Date Facility Aware | 2018-09-10 |
| Date Mfgr Received | 2018-09-10 |
| Date Added to Maude | 2018-10-04 |
| 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 | EI |
| 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 | 2018-10-04 |
| Model Number | BG3515-5-G |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-10-04 |