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

Catalog Number	5955790
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Seroma (2069); Hernia (2240)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with ventral hernia in the lower left abdominal wall thereby underwent open repair with implant of ventralex mesh (device 1) and bard flat mesh (device 2).Per op notes, ¿an incision was made in the left lower quadrant over a previous trocar site incision.The hernia sac was identified and divided off of the fascia.A ventralex mesh (device 1) was placed deep to the fascia and secured with multiple sutures.A bard flat mesh (device 2) was placed to overlap several centimeters in all directions and stapled to the fascia with sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with excision of ventralex mesh (device 1) and bard flat mesh (device 2) and implant of ventralight st with echo ps (device 3).Per op notes, ¿the hernia defect in the midline was identified.Adhesiolysis of fatty adhesions were made.Previously placed mesh (device 1 and 2) was noted to be within the hernia.It was excised completely and removed from the abdominal cavity.A ventralight st with echo ps (device 3) was placed and secured to the superior aspect of the pubic with tacks.¿ (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of ventralight st with echo ps (device 3) and implant of synthetic mesh.Per op notes, ¿an incision was made over the mesh.Dissection was carried down to the anterior abdominal wall.Mesh (device 3) was noted along the peritoneum and posterior rectus fascia as well incorporated.The mesh (device 3) was removed along with the wired clips used to hold the mesh in place.The defect in the anterior rectus fascia was noted.Seroma cavity between the anterior posterior rectus sheath was noted.Drain was placed in the seroma cavity.An onlay synthetic mesh was placed and secured with sutures.¿.
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 with echo ps (device 3).Additional supplemental emdrs were submitted to represent the ventralex mesh (device 1) and bard flat mesh (device 2).Note, the manufacturing date (15-oct-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.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 24757180
• Report Number: 1213643-2026-00418
• Device Sequence Number: 9101085
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(17)181128(10)HUAX2369
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/23/2026

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: 11/28/2018
• Device Catalogue Number: 5955790
• Device Lot Number: HUAX2369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2016
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 99 KG