MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-14 for BIOGLUE SURGICAL ADHESIVE BG3502-5-US manufactured by Cryolife, Inc..
[144997930]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[144997931]
According to the initial report,"i received a call from a plastic surgeon that used bioglue for a facelift procedure. The patient has a complaint of a mass under her skin that has presented post-op. The surgeon was inquiring if the application of bio-glue was responsible. " additional information received relays the plastic surgeon used the bioglue for a facelift procedure on both sides of face to adhere flaps. The patient came in for follow up two months post operatively complaining of mass. The patient's left side of face developed a mass postoperatively along suture line where bioglue was used. No intervention has been performed. Per a phone conversation on (b)(6) 2019 between the plastic surgeon and cryolife's medical director, it was discussed how the plastic surgeon could best remove the bioglue mass. The patient has reported pain, tingling and loss of feeling where the bioglue mass is located. The plastic surgeon dosen't remember the amount of bioglue used, but stated that half of the syringe was used on one side of the face and the other half was used on the patient's other side of face. Cryolife's medical director relayed that bioglue is used for large vessel anastomosis, and the use of bioglue during a facelift is an off label use. Cryolife's medical director also answered the plastic surgeon's question if the bioglue will go away (dissolve). Cryolife's medical director responded that it can take months up to 1 year before the bioglue will be reabsorbed. The plastic surgeon is planning to schedule the patient very soon for surgery to remove the bioglue mass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00028 |
| MDR Report Key | 8608601 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-14 |
| Date of Report | 2019-06-17 |
| Date Facility Aware | 2019-04-30 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-14 |
| 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 | 2019-05-14 |
| Model Number | BG3502-5-US |
| Catalog Number | BG3502-5-US |
| Lot Number | 18EUV006 |
| Device Expiration Date | 2019-10-10 |
| Device Availability | N |
| Device Age | DA |
| 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; 2. Required No Informationntervention | 2019-05-14 |