DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
|
Back to Search Results |
|
Catalog Number UNKAA097 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
|
Patient Problems
Inflammation (1932); Unspecified Tissue Injury (4559)
|
Event Date 07/20/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the information provided, no conclusion can be made.As reported, postoperative usage of the arista ah hemostatic agent the patient had an increase in tissue retraction and inflammation.It was reported that the patient¿s issue resolved and no additional treatment was required.The doctor does not recall removing/irrigating any of the residual arista powder after application.The warning section of the instruction for use supplied with this device states, " once hemostasis is achieved, excess arista¿ ah should be removed from the site of application by irrigation and aspiration" and also states, "arista¿ ah swells to its maximum volume immediately upon contact with blood or other fluids.Dry, white arista¿ ah should be removed." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is consider to be a best estimate as (b)(6) 2021 based on date of awareness.Should additional information be provided, a supplemental mdr will be submitted.
|
|
Event Description
|
As reported, the surgeon used the bard/davol arista ah hemostatic agent during a lumpectomy case.As reported, the surgeon did not recall removing/irrigating any of the residual arista powder after application.It was reported that, after evacuating a hematoma it was noticed the patient had an increase in tissue retraction and inflammation post operatively.As reported, the patient¿s issue resolved and there was no treatment.
|
|
Search Alerts/Recalls
|
|
|