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

Catalog Number	5954124
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069); Hernia (2240); Injury (2348)
Date of Event	04/04/2016
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) 2016.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged 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) 2016.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Per additional information provided: (b)(6) 2016 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with the implant of ventralight st mesh.Per operative notes, ¿all the adhesions were taken down from the upper midline hernia.Small bowel was densely adherent to the incision.Omentum was released.A ventralight st mesh was placed and secure it with suture.¿ (b)(6) 2016 - patient was diagnosed with midline incision drainage thereby underwent intrabdominal washout with evacuation of hematoma.(b)(6) 2016 - patient was diagnosed with recurrent incisional hernia with large hematoma, seroma thereby underwent open repair with the explant of ventralight st mesh and implant of biological mesh.Per operative notes, ¿drained a lot of seroma fluid out from on top of the ventralight st mesh.The mesh was floating in the cavity.A gray gelatinous old hematoma was behind the mesh.Hematoma and mesh were removed.Then, a biological mesh was placed and secure it with suture.¿ attorney alleges that the patient had abscess, adhesions, bowel obstruction, infection, pain and suffering.It was also alleged that the patient had hernia mesh protruded through skin.
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: this supplemental emdr is submitted to document additional information provided.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.Note, the manufacturing date (15-aug-2015) 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.

• 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: 11377066
• Report Number: 1213643-2021-01203
• Device Sequence Number: 14399360
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601(17)171028(10)HUZH1903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 10/28/2017
• Device Catalogue Number: 5954124
• Device Lot Number: HUZH1903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2015
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 106 KG