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

Catalog Number	5955113
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	02/03/2015
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: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of implant, brand name and pma/510(k).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.Updated fields: a2, b2, b3, b4, b5, b6, b7, d4 (product catalog no., udi no.), d6b (date of explant), g1, g3, g6, h2, h6, h10, h11.Corrected fields: d6a (date of implant), d1 (brand name), g4 (pma/510(k)).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
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 recurrent incisional hernia with obstruction thereby underwent laparoscopic repair with the implant of ventralight st w/ echo mesh (device 1).Per operative notes, ¿hernia sac was dissected out.There were multiple loops of small bowel adherent to the abdominal wall.All adhesions were taken down.A ventralight st w/ echo mesh was placed into the abdomen and secure it with sutures.¿ (b)(6) 2015 - patient was diagnosed with large abdominal wall abscess with infected mesh, ventral hernia recurrence, adhesion thereby underwent laparoscopic repair with explant of ventralight st w/ echo mesh (device 1).Per operative notes, ¿a midline incision was made just above the umbilicus.All abdominal wall abscess, adhesions were taken down.Previously placed infected ventralight st w/ echo mesh was removed.The defect was closed with sutures.¿ (b)(6) 2019 - patient was diagnosed with bowel obstruction, incarcerated hernia, multiple ventral hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device 2).Per operative notes, ¿a midline incision was made and carried into the abdominal cavity.Multiple hernia sac was identified; hernia sacs were dissected out.A ventralight st mesh (device 2) was placed into the defect and secure it with sutures.¿.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 8898797
• Report Number: 1213643-2019-07170
• Device Sequence Number: 329354
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Catalogue Number: 5955113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/05/2025
• 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: Disability; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male