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 Code	Abscess (1690)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, patient developed vaginal cuff abscess post usage of arista ah.Also reported is that the residual arista ah material was not removed from the surgical site following application as instructed in the instructions-for-use (ifu).The warning section of the ifu states, "once hemostasis is achieved, excess arista¿ ah should be removed from the site of application by irrigation." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is considered to be a best estimate as (b)(6) 2022 based on the information available.Device not returned.
Event or Problem Description
As reported, during an unknown procedure, arita ah was used on the vaginal cuff and residual material was not removed after hemostasis was achieved.As reported, the patient developed with vaginal cuff abscess.It was also reported that patient is presented to the emergency department visits on several occasions and the patient is doing well at this time.

• 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: 15982980
• Report Number: 1213643-2022-00794
• Device Sequence Number: 14926625
• Product Code: LMG
• UDI-Device Identifier: 00801741044144
• UDI-Public: (01)00801741044144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/29/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 12/14/2022
• 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 Sex: Female