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

Catalog Number	5955460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cellulitis (1768)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Attorney alleges that patient had bacterial infection and cellulitis post implant of ventralight st mesh using echo ps.The instructions-for-use supplied with the device identify infection as a possible complication.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 prosthesis.An unresolved infection may require removal of the prosthesis." this emdr represents ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent mesh ¿ ventralex (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.H3 other text : not returned.
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2015 - patient was diagnosed with supraumbilical ventral hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿ventral hernia was identified superior to umbilicus containing intra-abdominal fat and was reduced.A ventralex mesh (device #1) was secured circumferentially and hernia sac was closed over the mesh.¿ on (b)(6) 2015 - patient visited hospital for wound evaluation and had some drainage out of the superior margin of the incision.On (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh using echo ps (device #2) and removal of ventralex mesh (device #1).Per operative notes, ¿there were adhesions to the previously placed ventralex mesh (device #1) and were dissected out.A small defect was noted inferior and to right lateral side of the mesh (device #1) contained incarcerated omentum which was carefully removed.The ventralex mesh (device #1) was removed from the abdomen.A ventralight st mesh using echo ps (device #2) was placed and tacked to the anterior abdominal wall covering the mid defect.¿ on (b)(6) 2015 to (b)(6) 2017 - patient frequently visited hospital due to mid abdominal pain and dizziness.Attorney alleges that patient suffered "physical and/or bodily injury or symptoms resulting from the davol/bard hernia mesh product and emotional distress; patient developed a recurrence, there was a recurrent defect inferiorly and slightly to the right near the umbilicus contained incarcerated omentum and need for additional surgery." it is also alleged that patient "experienced abdominal pain, staph infection and a bacterial infection that was left behind the mesh when the doctor implanted it and treated with antibiotics in er between 2018 to 2019.Still treating the cellulitis.".

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 18718986
• Report Number: 1213643-2024-090703
• Device Sequence Number: 4499982
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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: 09/28/2017
• Device Catalogue Number: 5955460
• Device Lot Number: HUZH0845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 100 KG