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

Catalog Number	5955680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069)
Date of Event	11/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.As reported, patients experienced pain and seroma post implant of ventralight st mesh (w/ echo ps).No lot number has been provided; therefore, a review of the manufacturing records is not possible.Seroma and pain are known inherent risks of surgery and are identified in the instructions-for-use, supplied with the device as a possible complications.Note, the date of event is provided as an estimate ((b)(6) 2012) based on the information provided.Remains implanted.
Event or Problem Description
Per journal article: "comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial": purpose: the aim of this study was to compare two different mesh/fixation system concepts (non-bard/davol physiomesh/secure-strap (ph group) and ventralight st/sorbafix (vs group) for laparoscopic ventral hernia repair in 50 patients with respect to postoperative complications.Conclusion: the ph system was associated with significantly greater hernia recurrences and postoperative pain compared with the vs system.This confirms the superiority of the elastic (ventralight st) mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.This was single-center, prospective, randomized study designed to include 50 patients recruited for each group (ph & vs) from 01-nov-2012 to 31-aug-2013, with a planned interim analysis for safety after 25 patients.After the enrollment of 25 patients in both groups, the trial was terminated due to complications observed in the ph group.Five recurrences were observed in the ph group in the first 6 months and none in the vs group.Pain was noted in 22/ph, 20/vs at 7 days; 20/ph, 5/vs at 1 month; 14/ph, 0/vs at 3 months; 8/ph, 0/vs at 3 months.One seroma was observed in ph group and 2 seroma cases in vs group.

• 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: 16261210
• Report Number: 1213643-2023-00029
• Device Sequence Number: 4758176
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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 Catalogue Number: 5955680
• 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: 01/28/2023
• 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 Sex: Unknown