MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ARISTA AH; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

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.

• Brand Name: ARISTA AH
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12316180
• MDR Text Key: 266369331
• Report Number: 1213643-2021-20248
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention