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

Catalog Number	SM0007-USA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 g of the 5 g arista ah was used during a thyroidectomy procedure on (b)(6) 2023.The surgeon stated the residual arista ah material was not removed by irrigation or any other methods.As reported, the patient developed purulence less than 24 hours post op; thereby the patient was taken back to the or on (b)(6) 2023 for neck swelling, redness, pain and evacuation of purulence was performed.It was also reported that the patient was started on prophylactic antibiotics and the cultures were sterile.
Additional Manufacturer Narrative
It was reported that less than 24 hours post use of the bard/davol arista ah hemostatic powder, patient developed purulence and underwent evacuation.Based on the information provided, no conclusion can be made to what if any extent the arista product used caused or contributed to the patient's postoperative course.The surgeon stated that the residual arista ah material was not removed from the surgical site following application as instructed in the instructions-for-use (ifu).The warnings section of the ifu states, "once hemostasis is achieved, excess arista ah should be removed from the site of application by irrigation and aspiration".To date, this is the only reported complaint for this manufacturing lot.Not returned.

• Brand Name: ARISTA AH
• Common Device Name: 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: 16345551
• Report Number: 1213643-2023-00041
• Device Sequence Number: 20539168
• Product Code: LMG
• UDI-Device Identifier: 00801741044144
• UDI-Public: (01)00801741044144
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 Catalogue Number: SM0007-USA
• Device Lot Number: 6643301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Unknown