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	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930)
Date of Event	04/24/2014
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 bd ventralight st mesh (device 1).An additional supplemental emdr was submitted to represent the bd ventralex st mesh (device 2).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) 2013 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device 1) and ventralex st mesh (device 2).Per operative notes, ¿this was a recurrent hernia lateral to the old mesh that had been placed.Adhesions were lysed and the two defects in the left lower quadrant was noted, and a ventralight st mesh (device 1) was placed into the peritoneal cavity and tacked.In the right upper quadrant where the second hernia was noted and a ventralex st mesh (device 2) was placed into the peritoneal cavity and tacked.¿ (note: the previously placed mesh was unknown) (b)(6) 2014 ¿ patient was diagnosed with abdominal wall abscess thereby underwent open repair with removal of ventralight st mesh (device 1) and ventralex st mesh (device 2).Per operative notes, ¿a visible piece of ventralight st mesh (device 1) was noted and superior to this a ventralex st mesh (device 2) was also noted.There were a few loops of small bowel were densely adherent below the area of the infected mesh.The ventralight st mesh (device 1) and ventralex st mesh (device 2) were removed.¿.

• 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: 23615918
• Report Number: 1213643-2025-01110
• Device Sequence Number: 8977851
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)150428(10)HUXD1349
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 10/28/2025
• Initial Report FDA Received Date: 11/21/2025
• 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: 53 YR
• Patient Sex: Female