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

Catalog Number	5954450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	02/14/2021
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.Note, the manufacturing date (15-apr-2013) is considered to be a best estimate.This emdr represents the ventralight st mesh (device #2).Additional supplemental emdrs were submitted to represent the 3dmax (device #1) and perfix plug (device #4).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 additional information provided: (b)(6) 2012 ¿ patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #1).Per operative notes, ¿indirect inguinal hernia sac was dissected and large size 3dmax mesh (device #1) was placed and tacked and sutured.¿ (b)(6) 2013 ¿ patient was diagnosed with recurrent right inguinal hernia and left inguinal hernia and umbilical hernia thereby underwent laparoscopic and open repair with implant of ventralight st mesh (device #2) and two perfix plug (device #3 and #4).Per operative notes, ¿in left upper quadrant, a umbilical hernia defect was noted and placed with 3dmax mesh (device#2).In the left lower quadrant, medial defect in the cord was noted and perfix plug (device #3) was placed and sutured.In the right-side lower quadrant,¿ a large amount of scarring with direct hernia was noted.A perfix plug (device #4) was placed and sutured and tacked.¿ (b)(6) 2021 ¿ patient had adhesions, abdominal pain thereby underwent laparoscopic repair thereby underwent lysis of adhesions.Per operative notes, ¿omental adhesions were taken down, the mesh (device #2) was seen depressed in the centre and sutured.¿.

• Brand Name: VENTRALIGHT ST MESH
• 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: 22528809
• Report Number: 1213643-2025-00641
• Device Sequence Number: 7488252
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)150428(10)HUXD1349
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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 Expiration Date: 04/28/2015
• Device Catalogue Number: 5954450
• Device Lot Number: HUXD1349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2013
• 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: 59 YR
• Patient Sex: Male