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

Catalog Number	5954680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/15/2016
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 3).Two additional supplemental emdr was submitted to represent the bard composix e/x mesh (device 1) and ventralex 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) 2005 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of composix e/x mesh (device 1).Per operative notes, ¿an elliptical incision was made into the previous scar in the infraumbilical area.The incision was made and carried down to the midline fascia.The hernia sac was dissected out.A composix e/x mesh (device 1) was placed and secure it with sutures.¿ (b)(6) 2005 - patient was diagnosed with recurrent ventral hernia, thereby underwent open repair with implant of ventralex mesh (device 2).Per operative notes, ¿a standard midline incision was made over the palpable mass.The hernia sac was dissected out.A ventralex mesh (device 2) was placed in a subfascial position and secure it with sutures.¿ (b)(6) 2005 - patient was diagnosed with nonhealing abdominal wound thereby underwent open repair with drainage of wound fluid.(b)(6) 2014 - patient was diagnosed with small bowel obstruction, recurrent incisional hernia, adhesion, thereby underwent open repair with implant of ventralight st mesh (device 3) and explant of composix e/x mesh (device 1) and ventralex mesh (device 2).Per operative notes, ¿an incision was made into the right upper lateral quadrant.The hernia sac was dissected out.Multiple adhesions were noted between the small intestine and anterior abdominal wall.All adhesions were taken down.Previously placed (device 1 and device 2) was removed entirely.A 15.2 x 20.3 cam ventralight st mesh (device 3) was placed into the peritoneal cavity and secure it with sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of phasix mesh (device 4).Per operative notes, ¿an incision was made into the abdominal cavity of the prior surgical scar.The hernia sac was dissected out.A phasix mesh (device 4) was placed into the defect and sutured.¿.

• 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: 23897316
• Report Number: 1213643-2025-01275
• Device Sequence Number: 4552565
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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 Catalogue Number: 5954680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 51 YR
• Patient Sex: Female