MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-09 for FLOSEAL MATRIX HEMOSTATIC SEALANT FR0002 manufactured by Baxter Healthcare Corporation.
[574974]
Pt a: according to the reporter: a gyn surgeon at hosp circulated an email to her colleagues asking them if they had seen any incidence of tubal ovarian abscess in their postoperative ovarian cystectomy pts, in whom they had used floseal. The surgeon had seen 2 in the past few days/weeks and was looking for additional experiences. Reporter did not have any pt info to share and assured me that, in her opinion, this was not a serious situation. Baxter rn , asked reporter to notify the surgeon that she had spoken to her and that baxter was very interested in obtaining additional info. Reporter assured baxter rn that she would speak to the surgeon and tell her of baxter's responsiveness and interest in this concern.
Patient Sequence No: 1, Text Type: D, B5
[7920563]
Baxter med dir assessment: february 14, 2007. For the medical evaluation following clinical details are required. Diagnosis and indication for surgery; potential perioperative risk factors for infection (diabetes, intraoperative contamination, duration of surgery); course and outcome of infection, including confirmatory tests for abscess; lot number in both reported cases; similar adverse events with the same lot number; application method: excess of floseal removed or not, volume applied. A medical causality assessment is not possible based on the existing data. Multiple attempts have been made to acquire additional info regarding this case with no response from the nurse. If any further info comes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954761-2007-00004 |
| MDR Report Key | 827754 |
| Report Source | 05 |
| Date Received | 2007-03-09 |
| Date of Report | 2007-03-09 |
| Date of Event | 2007-02-09 |
| Date Mfgr Received | 2007-02-09 |
| Date Added to Maude | 2007-03-16 |
| 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 | HEMOSTATIC SEALANT |
| Product Code | EBC |
| Date Received | 2007-03-09 |
| 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 | 815159 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| 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 | 2007-03-09 |