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

Catalog Number	5954810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Purulent Discharge (1812); Necrosis (1971); Seroma (2069); Insufficient Information (4580)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st on (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st on (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with recurrent incisional prepubic hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿hernia sac was dissected, and a piece of ventralex mesh (device #1) was inserted into the abdominal cavity and secured using sutures.¿ (b)(6) 2010 - patient was diagnosed with incarcerated strangulated ventral incisional prepubic hernia and small bowel obstruction thereby underwent repair with mesh explant.Per operative notes, ¿dissected the hernia sac and there was ascitic fluid in abdominal cavity.The small bowel had protruded through this area.The previous ventralex mesh (device #1) was dissected out and the incorporated synthetic mesh was left in place.A synthetic mesh was then sutured circumferentially.(b)(6) 2011 - patient underwent exploratory laparotomy, closure of abdominal wound, exploration of scar and myomectomy.(b)(6) 2012 - patient underwent complex ventral hernia repair with removal of wadded up and protruding synthetic mesh.(b)(6) 2018 - patient was diagnosed with symptomatic complex ventral incisional hernia thereby underwent open repair with implant of ventralight st mesh (device #2).Per operative notes, ¿there were multiple defects, one by the umbilicus and several others had combination of small intestine and colon within sacs.A large fascial defect right above symphysis pubis.The hernia sacs were excised and a ventralight st mesh (device #2) was secured to undersurface of abdominal wall using sutures.¿ (b)(6) 2018 - patient was diagnosed with draining subcutaneous lower midline wound thereby underwent exploration and placed wound vac.Per operative notes, ¿the draining sinus opening was getting into complex subcutaneous wound.This all-above fascial level.There was no infected fluid it was more consistent with fatty necrosis.Very small amount of suture material was removed.A larger subcutaneous seroma in left vulva area was aspirated through open wound."" attorney alleges that the patient had adhesions, bowel obstruction, mesh migration, mesh shrinkage, pain, hernia recurrence, protruding mesh and balled mesh.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the patient id.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 months post implant of ventralight st mesh, patient was diagnosed with seroma, purulent drainage and necrosis thereby underwent repair.The instructions-for-use supplied with the device list seroma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-feb-2018) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st mesh (device #2).Additional supplemental emdr was submitted to represent the bard/davol 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.

• 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: 12291211
• Report Number: 1213643-2021-06690
• Device Sequence Number: 3165432
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687(17)200528(10)HUCP2512
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 05/28/2020
• Device Catalogue Number: 5954810
• Device Lot Number: HUCP2512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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: 106 KG