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

Catalog Number	5954113
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #1) used to treat the patient.The patient's attorney did allege surgical intervention; 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.This emdr represents the bard/davol ventralight st (device #1).An additional emdr was submitted to represent the bard/davol dulex (device #2).Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2016 or (b)(6) 2017, the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1) or an unspecified bard/davol dulex (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st (device #1) and dulex (device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Event or Problem Description
Attorney alleges that on (b)(6) 2016 or (b)(6) 2017, the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1) or an unspecified bard/davol dulex (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventralight st (device #1) and dulex (device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2016 - patient was diagnosed with ventral incisional and umbilical hernias thereby underwent laparoscopic repair with implant of dulex mesh (device #1).Per operative notes, ¿the ventral incisional hernia defect was identified and reduced.An umbilical hernia defect was identified and reduced.Both the hernias were repaired with dulex mesh (device #1) and tacked against the abdominal wall.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral and incarcerated umbilical hernias thereby underwent open repair with excision of dual mesh (device #1) and implant of ventralight st (device #2).Per operative notes, ¿the prior mesh was identified.The adhesions of mesh to abdominal wall were taken down.The entire mesh was removed along with tacks.Both ventral and umbilical hernia defects were identified and reduced.A ventralight st (device #2) was placed using prolene sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st (device #1) used to treat the patient.The patient's attorney did allege surgical intervention; 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-feb-2017) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st (device #1).An additional supplemental emdr was submitted to represent the bard/davol dulex (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.

• 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: 8629156
• Report Number: 1213643-2019-04145
• Device Sequence Number: 13995475
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595(17)190328(10)HUBP1909
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/02/2025

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: 03/28/2019
• Device Catalogue Number: 5954113
• Device Lot Number: HUBP1909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 136 KG