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

Catalog Number	5955600
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Skin Discoloration (2074); Burning Sensation (2146); Fluid Discharge (2686); Insufficient Information (4580)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, post implant of ventralight st w/ echo, the mesh ruptured and was explanted.No additional information has been provided upon request.Based on the information available, no conclusions can be made.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2023.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 alleged, during a procedure the patient was implanted with ventralight st w/ echo mesh.It was alleged the mesh ruptured post implant and on (b)(6) 2023 the patient underwent a 6-hour surgery to remove the mesh.
Additional Manufacturer Narrative
As alleged, post implant of ventralight st w/ echo, the mesh ruptured and was explanted.No additional information has been provided upon request.Based on the information available, no conclusions can be made.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2023.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document additional/corrected information provided.As initially reported the bd/bard mesh was explanted in 2023, however additional information provided states during the 2023 procedure the bd/bard mesh was implanted.As reported, post implant of ventralight st mesh (w/echo ps) the patient started experiencing a burning sensation, wound drainage, and discoloration at the surgical site.Based on the information provided, no conclusions can be made to the degree to which the implanted device may have caused or contributed to the patient¿s alleged post-surgical complications.Our records continue to show there have been no other reported complaints to date for this lot of (b)(4) units released for distribution in september 2023.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 alleged, during a procedure the patient was implanted with ventralight st w/ echo mesh.It was alleged the mesh ruptured post implant and on (b)(6) 2023 the patient underwent a 6-hour surgery to remove the mesh.Addendum per additional information provided: as reported, patient was diagnosed with an incisional hernia and underwent repair with implant of unknown mesh in 1995.As reported in (b)(6) 2023 patient had developed wound dehiscence, wound healing issues and drainage.On (b)(6) 2023 during umbilical hernia repair patient underwent removal of the previous mesh (unknown) and implant of a ventralight st mesh using echo ps.As reported, this past week ((b)(6) 2024) patient started experiencing a burning sensation, wound drainage and discoloration at the surgical site.Patient reached out to her surgeon and will be going to the hospital er on (b)(6) 2024 to have it evaluated.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 18613399
• Report Number: 1213643-2024-00019
• Device Sequence Number: 14045674
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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 Expiration Date: 06/28/2025
• Device Catalogue Number: 5955600
• Device Lot Number: HUHU1779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: 54 YR
• Patient Sex: Female