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	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of phasix mesh (device 1).Per op notes, "synthetic mesh was removed.Placed a phasix mesh (device 1) into the abdomen using tacks." (ppf/mrr).(b)(6) 2016 - patient was diagnosed with incarcerated incisional hernia thereby underwent robotic assisted laparoscopic repair with implant of ventralight st mesh using echo ps (device 2) and ventralight st (device 3).Per op notes, "adhesions were taken down.Noted the mesh (device 1) in the abdominal wall.A ventralight st mesh using echo ps (device 2) and a ventralight st (device 3) were placed to cover the previous mesh (device 1) into the abdominal wall using prolene sutures." (ppf/mrr).(b)(6) 2017 - patient was diagnosed with recurrent epigastric incisional hernia thereby underwent laparoscopic repair with the implant of phasix mesh (device 4) and lysis of adhesions.Per op notes, "lysis of adhesions was performed, separated the mesh from the healthy fascia.A phasix mesh (device 4) was placed using sutures." (ppf/mrr).
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.Note, the manufacturing date (15-sep-2015) is considered to be a best estimate.This mdr represents the ventralight st mesh using echo ps (device 2).Additional supplemental emdrs were submitted to represent the phasix mesh (device 1) and ventralight st mesh (device 3).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: 23786739
• Report Number: 1213643-2025-01186
• Device Sequence Number: 13375305
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(11)171028(10)HUZI0914
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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 Expiration Date: 10/28/2017
• Device Catalogue Number: 5955600
• Device Lot Number: HUZI0914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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: 50 YR
• Patient Sex: Female