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

Catalog Number	5954680
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/28/2018
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.This mdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st mesh (device 1).Note, the manufacturing date (15-may-2016) is considered to be a best estimate.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 two separate incisional hernias thereby underwent laparoscopic repair with implant of ventralight st mesh (device 1 and 2).Per op notes, ¿a left subcoastal stab incision was made.Hernia defects were identified which were slightly obscured by the omentum and it was taken down.Two separate hernias were noted.Midline hernia just above the umbilicus and left lower quadrant hernia.The fascial defects were closed with absorbable suture and trans-fascial sutures.A ventralight st mesh (device 1) was placed intra-abdominally and anchored to the anterior abdominal wall with suture and absorbable tacks which covered the midline fascial defect.A ventralight st mesh (device 2) was placed to cover the left lower quadrant fascial defect and secured to the abdominal wall with suture and absorbable tacks.¿ (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent robotic assisted laparoscopic repair with excision of ventralight st mesh (device 1 and 2) and implant of synthetic mesh.Per op notes, ¿a left subcoastal stab incision was made.Adhesions in the left upper and lower quadrant and mid abdominal wall were noted and lysed.The hernia defect was identified and noted an even traction of previously placed mesh (device 1 and 2) into the hernia sac.Hernia sac was incised and the previously placed mesh were completely mobilized out of the hernia defect, amputated and set aside.The defect was then closed with suture.A synthetic mesh was placed to the anterior abdominal wall and secured 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: 24797625
• Report Number: 1213643-2026-00439
• Device Sequence Number: 10706937
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)180528(10)HUAS1067
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2018
• 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: 05/28/2018
• Device Catalogue Number: 5954680
• Device Lot Number: HUAS1067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 101 KG