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	Hematoma (1884); Unspecified Infection (1930)
Date of Event	11/27/2019
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.Note, the manufacturing date (15-jun-2019) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 2).An additional emdr was submitted to represent the ventralight st mesh using echo ps (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.
Event or Problem Description
Per information provided: on (b)(6) 2018 - patient was diagnosed with symptomatic incarcerated ventral incisional hernia thereby underwent open 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 abdomen through the midline defect using sutures." on (b)(6) 2019 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the removal of mesh (device 1) and implant of ventralight st mesh (device 2).Per op notes, "the previous mesh was noted folding into the inferior aspect of the hernia defect.The omental adhesions to the anterior abdominal wall including the previous mesh were then taken.The recurrent hernia was identified.A small midline incision was then made, ventralight st mesh (device 2) was then placed using tacks." on (b)(6) 2019 - patient was diagnosed with infected hematoma abdominal wall thereby underwent incision and drainage.Per op notes, "the patient had hematoma to the left of midline.The fascia appeared intact and there was no evidence of mesh involvement.".

• 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: 24698229
• Report Number: 1213643-2026-00381
• Device Sequence Number: 10440124
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)210728(10)HUDT2109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 07/28/2021
• Device Catalogue Number: 5954450
• Device Lot Number: HUDT2109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2019
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG