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	09/25/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, sixteen days post-implant of the bard/davol ventralight st mesh, the patient was diagnosed with purulent incisional drainage and bacterial wound infection and was treated with both oral and iv antibiotics.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Infection is a known inherent risk of the surgery/usage of device.The instructions-for-use (ifu) supplied with the device list infection as a possible complication.In regards to infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." this mdr represents the ae of surgical wound infection.An additional mdr was submitted to represent the ae of midline incision wound opening.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2013 - subject patient underwent open recurrent midline hernia repair procedure during which a bard/davol ventralight st mesh was implanted with sutures.Full skin closure was achieved using adhesive skin closure.The patient was discharged to home on (b)(6) 2013.(b)(6) 2013 - subject patient was presented with purulent incisional drainage and diagnosed with surgical wound infection.Subject patient was admitted to hospital for intravenous (iv) antibiotics and culture tested positive for methicillin-resistant staphylococcus aureus (mrsa).Peripherally inserted central catheter (picc) line was placed and patient was treated with intravenous (iv) and oral antibiotics.The subject patient was discharged to home on (b)(6) 2013.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.(b)(6) 2013 - subject patient was diagnosed with midline incision wound opening during the period of incisional infection.As reported, the patient was treated with intravenous (iv) and oral antibiotics and the wound was resolved.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported has 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: 14489033
• Report Number: 1213643-2022-00309
• Device Sequence Number: 11932324
• 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: 2013
• 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: 04/28/2015
• Device Catalogue Number: 5954113
• Device Lot Number: HUXD1362
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 104 KG