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 Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	04/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 1 year post-implant of the bard/davol ventralight st mesh, patient was diagnosed with hernia recurrence.As reported, no action has been taken and it was not-resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the ae of hernia recurrence.An additional mdr was submitted to represent an additional ae of seroma.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2013 - subject patient underwent a primary laparoscopic hernia repair and was implanted with a bard/davol ventralight st mesh.The hernia defect was 23 x 13 cm extending from old ostomy site to midline.The mesh was fixated using mechanical fixation (sorbafix) and sutures.Fascia closure was achieved; full skin closure was achieved using adhesive skin closure.The patient was discharged from the hospital on (b)(6) 2013.On (b)(6) 2014 - subject patient presented with abdominal pain and right upper quadrant bulge after coughing fit.The surgeon requested a ct to rule out recurrence; patient did not undergo ct or returned to clinic.On (b)(6) 2014 - patient was diagnosed with incisional hernia recurrence during physical exam.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and to the index procedure.The outcome for this ae is reported as not recovered/ not 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: 14454871
• Report Number: 1213643-2022-00248
• Device Sequence Number: 6418946
• 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): 05/12/2022

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: 10/28/2014
• Device Catalogue Number: 5954113
• Device Lot Number: HUWJ1592
• 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
• Date Device Manufactured: 10/31/2012
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 119 KG