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

Catalog Number	5954810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	02/28/2019
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-feb-2016) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 3).Additional supplemental emdr¿s were submitted to represent the ventralight st mesh (device 1) and ventralight 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) 2016 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with implant of ventralight st (device 1).Per op notes, ¿the hernia sac was identified in the right upper abdomen and dissected free.The bowel incarcerated in hernia was reduced.Adhesions were lysed.Omental adhesions were lysed.A ventralight st (device 1) was placed and tacked using sorbafix tacker.¿ (b)(6) 2016 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with excision of ventralight st (device 1) and implant of ventralight st (device 2 and 3).Per op notes, ¿the previous sutures were removed.The previous incision was opened.Adhesions were lysed.The prior mesh (device 1) was identified and excised.Intra-abdominal adhesions were lysed.A large hernia defect was noted and excised the sac.Two ventralight st (device 2 and 3) were placed and sutured together.¿ (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of ventralight st (device 2 and 3).Per op notes, ¿midline scar was opened.Filmy adhesions of small bowel to abdominal wall were lysed.The hernia was identified just right of midline.The prior meshes (device 2 and 3) were noted failed and excised.The hernia was repaired primarily with sutures.¿.

• 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: 24484112
• Report Number: 1213643-2026-00263
• Device Sequence Number: 20078551
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687(17)180228(10)HUAP0714
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/18/2026

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: 02/28/2018
• Device Catalogue Number: 5954810
• Device Lot Number: HUAP0714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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: 37 YR
• Patient Sex: Female