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

Catalog Number	5954790
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Per legal complaint: (b)(6) 2015 - patient underwent surgery during which the patient was implanted with an unspecified bard/davol ventralight st.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.".
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.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-oct-2014) is considered to be a best estimate.Updated fields: a2, b2 (outcomes attributed to adv ev), b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), g3, g6, h2, h4, h6, h10.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 legal complaint: (b)(6) 2015 - patient underwent surgery during which the patient was implanted with an unspecified bard/davol ventralight st.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." addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the implant of ventralight st mesh (device 1).Per operative notes, ¿hernia sac was dissected out.Lysis of adhesion was performed.A ventralight st mesh (device 1) was placed into the abdominal cavity and secure it with sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia, adhesion underwent open primary hernia repair.Per operative notes, ¿a lower midline skin incision was made.Hernia sac was dissected out.The hernia defect was primary fascial closer with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿a midline incision was made.Hernia sac was dissected out.A synthetic mesh was placed retro rectus position into the defect and sutured.¿.

• Brand Name: VENTRALIGHT ST
• 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 boulevard; warwick, RI 02886 ; 4018258495
• MDR Report Key: 8465963
• Report Number: 1213643-2019-02254
• Device Sequence Number: 16888528
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663(17)161028(10)HUYJ0853
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 10/28/2016
• Device Catalogue Number: 5954790
• Device Lot Number: HUYJ0853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• 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; Disability
• Patient Age: 47 YR
• Patient Sex: Female