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

Catalog Number	5954800
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	08/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; 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.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.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) 2019.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.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." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; 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-dec-2017) 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) 2019.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2019- patient was diagnosed with incarcerated incisional hernia thereby underwent robotic assisted laparoscopic repair with implant of ventralight st.Per op notes, ¿chronically incarcerated omentum from multiple defects were identified in the lateral left abdomen and reduced.A ventralight st mesh was placed on the defects and sutured.¿.(b)(6) 2021- patient was diagnosed with small bowel obstruction with abdominal pain, thereby underwent open repair.Per op notes, ¿adhesions were noted from the previous incisional hernia repair and adhesiolysis was performed.Small bowel obstruction was noticed and resected¿.(b)(6) 2021- patient was diagnosed with possible anastomotic leak, thereby underwent open repair.Per op notes, ¿it was noted that the subcutaneous tissue was necrotic and some necrotic muscle fascia.It was noted that there was a large disruption in the staple line when there was a leakage of succus.¿.(b)(6) 2021- patient was diagnosed with possible anastomotic leak, thereby underwent open repair.Per op notes, ¿the fascia was clearly necrotic and was debrided along with abdominal wall skin and fat.¿ (b)(6) 2021- patient was diagnosed with lleostomy, thereby underwent open repair.Per op notes, ¿small bowel was found adherent to the abdominal wall and adhesiolysis was performed.There was a significant portion of abdominal wall and mesh that had to be removed to remove the small bowel from anterior abdominal wall.This defect was then sutured.¿ (b)(6) 2022- patient was diagnosed with abscess plan drainage thereby underwent open repair.

• 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: 16972654
• Report Number: 1213643-2023-092069
• Device Sequence Number: 2543447
• Product Code: FTL
• UDI-Device Identifier: 00801741031670
• UDI-Public: (01)00801741031670(17)191228(10)HUBZ0400
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 12/28/2019
• Device Catalogue Number: 5954800
• Device Lot Number: HUBZ0400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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: 67 YR
• Patient Sex: Female