FDA Adverse Event
Injury
Summary report: N
HEMOBLAST BELLOWS
MDR report key: 12224555
·
Received July 26, 2021
Report
- Report Number
- 3007702492-2021-00001
- Event Type
- Injury
- Date Received
- July 26, 2021
- Date of Event
- June 18, 2021
- Report Date
- July 23, 2021
- Manufacturer
- BIOM'UP FRANCE SAS
- Product Code
- PMX
- UDI-DI
- 03760193182705
- PMA / PMN Number
- P170012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SURGEON PERFORMED BREAST RECONSTRUCTION WITH EXPANDER. HEMOBLAST WAS APPLIED AFTER TISSUE REMOVAL AND HEMOSTASIS WAS ACHIEVED. THE SURGEON REPORTED THAT EXCESS HEMOBLAST WAS NOT REMOVED. THE PRODUCT IFU INSTRUCTS THAT ONCE HEMOSTASIS IS ACHIEVED, EXCESS HEMOBLAST SHOULD BE REMOVED FROM THE APPLICATION SITE BY IRRIGATION AND ASPIRATION.
Description of Event or Problem · 1
TWO DAYS AFTER BREAST RECONSTRUCTION SURGERY, PATIENT WAS BROUGHT BACK TO OR TO EVACUATE A 400CC SEROMA. SEROMA FORMATION WAS ATTRIBUTED TO CLOGGED DRAIN. SURGEON REPORTED THE DRAIN WAS CLOGGED FROM THE HEMOBLAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1121505 | HEMOBLAST BELLOWS | HEMOSTATIC AGENT | PMX | BIOM'UP FRANCE SAS | BQF02 | 03760193182705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | KCI PREVENA RESTOR BELLA-FORM INCISION MANAGEMENT |