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

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed an infection thereby underwent revision surgery post usage of arista ah.Contact information was not provided.Based on the information available, no conclusions can be made as to the degree to which the product may have caused or contributed to the patient¿s clinical course.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Postoperative infection is a known inherent risk of surgery.This emdr represents the arista ah.An additional emdr was submitted to represent the phasix mesh.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported per medwatch form (mw5155891): "hernia mesh implant resulting in infection revision surgery and prolonged infection.Cr bardmesh hrna repair 25cmx31cm implant type: mesh/peg, implanted area: abdomen laterality: implanted on (b)(6) 2023.Number implanted: 1 status: implanted, manufacturer cr bard, model number: 1190500, lot number: hugz0902, serial number: sealnt pwdr hemos 3gm arista implant type sealant implanted area: abdomen laterality: n/a implanted on (b)(6) 2023.Number implanted: 2 medical center revision surgery (b) (6) after mri and bloodwork showed abdominal infection.Hospitalized third time (b)(6) with recurring infection.Blood work and antibiotics for three days." this file represents the arista ah.

• 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: 19761177
• Report Number: 1213643-2024-00366
• Device Sequence Number: 18271211
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: SM0002-USA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 94 KG