MAUDE Adverse Event Report: BIOM'UP SA HEMOBLAST BELLOWS; HEMOSTATIC AGENT

Model Number	BQF02
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biom'up contacted the surgeon the day after receiving the report.The surgeon provided the following feedback: the area was dry when he closed.He believes the surrounding tissue had adhered together closing off the area in which the hematoma formed from the drain.He suspects the bleeding began when the patient rubbed his cheek, causing mechanical disruption, during the time between discharge and the post-operative visit the following morning.Dr.(b)(6) does not feel the hematoma is in anyway related to the hemoblast bellows.
Event or Problem Description
Surgeon reported that a small hematoma had formed on the right side of a male patient's face following a facelift in which hemoblast¿ bellows was used.The drain was noted to be placed superior to the hematoma.The hematoma was identified the day after surgery, in a spot superior to the drain near the ear.The surgeon evacuated 1-2 mls of blood from the area.

• Brand Name: HEMOBLAST BELLOWS
• Common Device Name: HEMOSTATIC AGENT
• Manufacturer (Section D): BIOM'UP SA; 8 allee irene joliot curie; saint-priest, rhone 69800 ; FR 69800
• MDR Report Key: 8781832
• Report Number: 3007702492-2019-00002
• Device Sequence Number: 1937620
• Product Code: PMX
• UDI-Device Identifier: 03760193182705
• UDI-Public: 03760193182705
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P170012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2018
• Device Model Number: BQF02
• Device Catalogue Number: BQF02-US
• Device Lot Number: BQF17030.134149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention