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); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #2) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st (device #2).An additional emdr was submitted to represent the bard/davol ventralight st (device #1).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 (device #1) on (b)(6) 2015 and an unspecified ventralight st (device #2) on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventralight st (device #1) and (device #2).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.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1) on (b)(6) 2015 and an unspecified ventralight st (device #2) on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventralight st (device #1) and (device #2).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) 2015 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic repair with implant of ventralight st (device #1).Per operative notes, ¿the hernia defect was identified with incarcerated omentum.The omentum was dissected out from hernia sac.The hernia sac was excised.A ventralight st (device #1) was placed and tacked." (b)(6) 2015 - patient was diagnosed with abdominal wall seroma thereby underwent open repair with aspiration of fluid.Per operative notes, ¿the seroma was identified, and the needle was inserted.The serous fluid was aspirated." (b)(6) 2017 - patient was diagnosed with chronically incarcerated recurrent incisional hernia thereby underwent open repair with excision of ventralight st (device #1) and implant of ventralight st (device #2).Per operative notes, ¿the hernia defect was identified with incarcerated omentum and colon which was adherent to previous mesh was taken down.The mesh (device #1) had pulled away from the abdominal wall and herniated.The incarcerated colon and omentum were dissected.The prior mesh (device #1) was excised along with a part of omentum.A ventralight st (device #2) was placed and sutured.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #2) used to treat the patient.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-mar-2017) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol ventralight st mesh (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. -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: 8732716
• Report Number: 1213643-2019-05425
• Device Sequence Number: 1685194
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601(17)190428(10)HUBQ1846
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 04/28/2019
• Device Catalogue Number: 5954124
• Device Lot Number: HUBQ1846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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
• Patient Sex: Female