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

Catalog Number	5955460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bowel Perforation (2668)
Date of Event	01/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: (b)(6) 2009 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex (device #1) mesh.Per operative notes, ¿the umbilical hernia was noted and dissected.A large ventralex mesh (device #1) was placed over the defect and sutured in place.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent symptomatic ventral incisional umbilical hernia and pain thereby underwent laparoscopic repair with partial removal of ventralex mesh (device #1) and implant of ventralight st using echo ps (device #2).Per operative notes, ¿adhesions of omentum and hernia defect were removed.The hernia defect in supraumbilical side was noted.The mesh (device #1) was seen bundled up below the defect.The portion of the mesh (device #1) was removed and ventralight st using echo ps (device #2) mesh was placed in the epigastric area and tacked circumferentially.¿ (b)(6) 2018 - patient was diagnosed with small bowel laceration thereby underwent open repair with removal of old meshes (device #1 and #2) and small bowel resection.Per operative notes, ¿the small bowel was resected.Adhesions and old meshes (device #1 and #3) were removed and defect was closed with sutures.¿.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This emdr represents the ventralight st using echo ps (device #2).An additional supplemental emdr was submitted to represent the ventralex mesh (device #1) 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.

• 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: 22529135
• Report Number: 1213643-2025-00643
• Device Sequence Number: 18149728
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 5955460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male