MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about five years post-implant of the bard/davol ventralight st mesh, the patient was diagnosed with intra-abdominal bacterial mesh infection and underwent mesh explant.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being "definitely" related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Infection is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists infection as a possible complication.The warnings section states that, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." 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.Not returned - mesh explanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2014 - subject patient underwent an open first time recurrent incisional hernia (10x20 cm, llq) repair procedure.A bard/davol ventralight st mesh was placed using mechanical fixation and sutures.Full skin closure was achieved using staples.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2019 - subject patient was diagnosed with intra-abdominal bacterial/mesh infection.Drainage noted during appointment.Culture positive for finegoldia magna, treated with iv antibiotics.On (b)(6) 2019 - subject patient underwent complete mesh excision with drain placement.The patient was discharged to home on (b)(6) 2019.Per the study clinician, the reported adverse event has been assessed as severe in severity, definitely related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14454628
• Report Number: 1213643-2022-00245
• Device Sequence Number: 15037989
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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 Expiration Date: 11/28/2015
• Device Catalogue Number: 5954113
• Device Lot Number: HUXK0054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/20/2022
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG