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

Catalog Number	5954610
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Fluid Discharge (2686)
Date of Event	07/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Additional Manufacturer Narrative
At this time no conclusions can be made.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 8 months post implant of ventralight st mesh, patient was diagnosed with infection, hernia recurrence, adhesions and fluid discharge thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists infection, hernia recurrence and adhesions as possible complications.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-aug-2012) 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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using ps (device #1).Per operative notes, ¿a large ventral hernia extends above the umbilicus to lower abdomen.The omentum in the hernia sac were taken down.A ventralight st mesh using ps (device #1) was placed into the defect and secured with sutures.¿ (b)(6) 2014 - patient was diagnosed with recurrent reducible ventral hernia thereby underwent open repair.Per operative notes, "the hernia sac was removed.The adhesions were taken down sharply.The bowel mesentery was stuck to the old ventralight st mesh using ps (device #1), and the recurrence has happened in the lower abdomen where the lowest stitch had failed, and the laparoscopic tacks had failed to take hold of the fascia.The mesh was reattached where it came away from the abdominal wall in the lower abdomen was sutured into place with interrupted suture.¿ (b)(6) 2014 - patient was diagnosed with infected ventral mesh thereby underwent open repair with the removal of ventralight st mesh using ps (device #1) and implant of xenmatrix (device #2).Per operative notes, ¿there was some serous fluid on top of the mesh.The ventralight st mesh using ps (device #1) was removed.The adhesions were taken down sharply.A seprafilm was placed over the small bowel and the omentum is layed down over the small bowel.The xenmatrix (device #2) was placed into the peritoneal cavity and sutured.¿ (b)(6) 2015 - patient was diagnosed with adhesion thereby underwent repair.Per operative notes, ¿the fascia to the xenmatrix mesh (device #2) was dissected.Adhesion were taken down.Appendectomy was done.¿ attorney alleged that the patient had adhesions, infection, pain and hernia recurrence.

• 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 ; 4018258495
• MDR Report Key: 8914869
• Report Number: 1213643-2019-07322
• Device Sequence Number: 11451338
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649(17)140828(10)HUWH1080
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 08/28/2014
• Device Catalogue Number: 5954610
• Device Lot Number: HUWH1080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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: Disability; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female