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)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's 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."; however, no details have been provided.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 ventralex 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 ventralex st and ventralight st on (b)(6) 2013 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is also alleged that the patient sustained unspecified injuries on (b)(6) 2014 and/or (b)(6) 2016.Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe, permanent personal injuries." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's 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."; 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-may-2012) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st mesh (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventralex st (device #2).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 ventralex st and ventralight st on (b)(6) 2013 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both the devices.It is also alleged that the patient sustained unspecified injuries on (b)(6) 2014 and/or (b)(6) 2016.Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe, permanent personal injuries." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralight st (device #1).Per op notes, ¿three pieces of meshes were removed.Placed a ventralight st mesh (device #1) in the retrorectus space.¿ (note: unknown meshes were removed during this procedure).(b)(6) 2014 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of ventralex st (device #2).Per op notes, ¿taken down the adhesions between the omentum and anterior abdominal wall.A ventralex st mesh (device #2) was placed it in an underlay fashion using prolene sutures.¿ (note: the previously placed ventralight st mesh (device #1) was not seen during this procedure).(b)(6) 2016 - patient was diagnosed with recurrent incisional hernia with chronic abdominal wall pain thereby underwent repair with the removal of mesh (device #1 & #2).Per op notes, ¿there was hernia recurrence between the previously placed mesh (device #1 & #2).Noted significant amount of inflammation and scar tissue around the ventralex st (device #2).The mesh (device #1 & #2) was removed.¿.

• 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: 9966132
• Report Number: 1213643-2020-03527
• Device Sequence Number: 3940171
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601(17)140528(10)HUWE0616
• 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: 2013
• 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): 05/26/2025

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: 05/28/2014
• Device Catalogue Number: 5954124
• Device Lot Number: HUWE0616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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: 40 YR
• Patient Sex: Female