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

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the alleged postoperative complication cannot be determined at this time.The information provided at this time is limited.Efforts have been made to gather additional case specific information.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaints of inflammation for the subject lot of (b)(4) units manufactured in april of 2017.Should additional information be provided a supplemental emdr will be submitted.Used on patient.
Event or Problem Description
It was reported that the patient experienced an abscess that required antibiotics and drainage post-operatively after use of the arista ah product.The surgeon is a first-time user of the arista.

• Brand Name: ARISTA AH ABSORBABLE HEMOSTAT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9099818
• Report Number: 1213643-2019-09057
• Device Sequence Number: 14119449
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 02/28/2022
• Device Catalogue Number: SM0002-USA
• Device Lot Number: 5774201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/20/2019
• 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