MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-03-17 for FLOSEAL MATRIX HEMOSTATIC SEALANT FR0002 manufactured by Fremont.
[21698549]
Date of occurence: estimated feb 2006. The patient was present and surgery was successful. Event description: patient underwent anterior cervical disc surgery (2 to 3 levels). Approximately midway through the case, the anethesiologist stated that the pulse oximeter reading had been lost as well as the arterial line reading, both in the right arm. The circulating nurse checked the right arm under the drapes. The nurse stated the arm was cold and there was no capillary refill. A vascular surgeon was asked to come in and evaluate the arm. The cervical disc was completed, and the vascular surgeon proceeded to endoscopically remove a clot from the right arm. The clot was sent to pathology. The surgeon stated that the patient did not wake up how she have liked, and later during her recovery the patient was found to have intracranial infarcts. The patient was also found to have a patent foramen ovale. The pathologist, reported to another dr that the clot had "characteristics similar to floseal". This report concerned second dr and she felt it was important to bring it to the attention of baxter second dr stated the patient was in a flat position, and that each time floseal was used, it was placed onto active bleeding site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954761-2006-00003 |
| MDR Report Key | 689852 |
| Report Source | 05 |
| Date Received | 2006-03-17 |
| Date of Report | 2006-03-17 |
| Date of Event | 2006-02-07 |
| Date Mfgr Received | 2006-02-22 |
| Date Added to Maude | 2006-03-21 |
| 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 | 0 |
| Manufacturer Contact | JOSHUA LEACH, SPECIALIST |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723250 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOSEAL MATRIX HEMOSTATIC SEALANT |
| Generic Name | DEVICES |
| Product Code | EBC |
| Date Received | 2006-03-17 |
| Model Number | FR0002 |
| Catalog Number | FR0002 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 679029 |
| Manufacturer | FREMONT |
| Manufacturer Address | 34175 ARDENWOOD BLVD. FREMONT CA 94555 US |
| Baseline Brand Name | FLOSEAL MATRIX HEMOSTATIC SEALANT |
| Baseline Generic Name | DEVICES |
| Baseline Model No | FR0002 |
| Baseline Catalog No | FR0002 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-17 |