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

Catalog Number	5954460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	10/18/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with large right lower quadrant anterior abdominal wall incarcerated incisional hernia with small bowel obstruction thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, "the hernia defect in the right lower quadrant was noted to be quite large with incarcerated bowel.Enterolysis was performed.Second hernia was superior near the umbilicus, this was repaired.A composix e/x mesh (device #1) was placed on undersurface of fascia and sutured." (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia at right lower quadrant and adhesions thereby underwent laparoscopic repair.Per operative notes, "dense adhesions were encountered.Two loops of bowel stuck in the hernia sac was reduced.The small bowel adhered to the edge of mesh (device #1) and hernia sac itself.A portion of seromuscular layer in the mesh was excised.The bowel was repaired.The fascial defect also was repaired with sutures, reapproximating the old mesh (device #1) superiorly and laterally.A piece of biologic mesh was placed." (b)(6) 2013 - patient was diagnosed with seroma at right lower quadrant incisional hernia site thereby underwent drainage of seroma.(b)(6) 2014 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with the implant of ventralight st mesh (device #2).Per operative notes, "the sac was opened and several loops of small intestine were adherent.A piece of mesh (device #1) was seen in lower abdomen.The fascial defect was at superior margin of mesh.The adhesions were taken down.A piece of ventralight st mesh (device #2) was placed on undersurface of fascia and sutured." (b)(6) 2014 - patient was diagnosed with abdominal wall seroma thereby underwent drainage.Ni-ni, patient got infected and the entire mesh (device #2) was removed.Attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, hernia recurrence, ring break, seroma, infection, pain and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, post implant of ventralight st, patient was diagnosed with unspecified infection and seroma.The instruction for use supplied along with the device lists infection and seroma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-may-2014) is considered to be a best estimate.This emdr represent the ventralight st (device #2).An additional supplemental emdr was submitted to represents the composix e/x mesh (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.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 21906693
• Report Number: 1213643-2025-090171
• Device Sequence Number: 4221248
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)160528(10)HUYE0508
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/25/2025

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 Expiration Date: 05/28/2016
• Device Catalogue Number: 5954460
• Device Lot Number: HUYE0508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 122 KG