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

Catalog Number	5954124
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.Additional information was provided in follow up and states there was no specific postoperative complaint or additional surgical intervention required.Article notes postoperative bulging is common following standard ipom repairs of large size hernias.Note, the date of event (b)(6) 2020 is provided as an estimate based on information provided.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.Remains implanted.
Event or Problem Description
Per journal article: "feasibility of using a tailored mesh in laparoscopic sugarbaker parastomal hernia repair".Background: in parastomal hernia (ph) repair laparoscopic sugarbaker technique (ls) is considered the best practice; however, meshes specific for ls repairs ceased to be available.Purpose: the aim of the study was to evaluate feasibility of using a physician modified mesh (tailored mesh, ventralight st mesh) in laparoscopic sugarbaker technique.Conclusion: in laparoscopic sugarbaker technique tailored mesh (ventralight st mesh) seems to be a feasible mesh comparable to specific parastomal mesh (non-bard mesh) within short- and mid-term follow-up.Article states one patient treated with ventralight st mesh for a large defect experienced mesh ¿bulging¿ 1-year postoperatively, as seen on imaging.Per article, bulging commonly develops following standard ipom repairs of large size hernias.

• 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: 16272254
• Report Number: 1213643-2023-00033
• Device Sequence Number: 6082797
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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: 01/28/2020
• Device Catalogue Number: 5954124
• Device Lot Number: HUBZ0766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/31/2023
• 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: 62 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG