MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2019-03-18 for BIOGLUE SURGICAL ADHESIVE BG3502-5-G manufactured by Cryolife, Inc..
[139111034]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[139111035]
According to the initial report, another case occurred by similar this mass effect has popped up and [the surgeon] reviewed this patient who had neuro surgery of spinal tumor at lumbar spine before. According to the report the operating surgeon relays that this patient had a decompressive laminotomy for spinal stenosis where bioglue was used. The bioglue was applied to the dura after suturing. The area was dry when the bioglue was applied. It was then discovered that the bioglue had formed a mass. The patient still had persistent leg pain after the decompression.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00011 |
| MDR Report Key | 8429762 |
| Report Source | CONSUMER,FOREIGN,USER FACILIT |
| Date Received | 2019-03-18 |
| Date of Report | 2019-06-07 |
| 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. Other | 2019-03-18 |