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

Catalog Number	5955600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bowel Perforation (2668)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
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 bard/davol ventralight st w/ echo (device #3).An additional supplemental emdr was submitted to represent the bard/davol ventralight st w/ echo (device #1 & #2).Note, the manufacturing date (15-jun-2017) is considered to be a best estimate.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
Per information provided: (b)(6) 2014 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device #1).Per op notes, ¿a ventralight st mesh using echo ps (device #1) was placed in the anterior abdominal wall using tackers.¿ (b)(6) 2017 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of two ventralight st mesh using echo ps (device #2 & #3).Per op notes, ¿there were adhesions extending from the mid to lower abdomen.There was an edge of the old mesh (device #1) that had curled over.Two ventralight st mesh using echo ps (device #2 & #3) were placed in the abdomen to cover the old mesh.¿ (b)(6) 2019 - patient was diagnosed with abdominal wall abscess with perforated cecum thereby underwent repair with removal of mesh (device #1, #2 & #3).Per op notes, ¿a moderate amount of purulent fluid was noted.Performed adhesiolysis.Identified the perforation of the cecum and was taken down.There was a retained foreign body, which appeared to be a previously placed echo mesh (device #1, #2 & #3).This was noted to be intracorporeal in the cecum and was removed in its entirety.¿.

• 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: 22132947
• Report Number: 1213643-2025-00424
• Device Sequence Number: 15585049
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(17)190728(10)HUBT0982
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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 Expiration Date: 07/28/2019
• Device Catalogue Number: 5955600
• Device Lot Number: HUBT0982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female