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

Catalog Number	5955610
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Injury (2348)
Date of Event	11/28/2016
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.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.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2012 or (b)(6) 2016, the patient underwent surgery, which included implant of the following unspecified bard/davol hernia mesh devices; sepramesh ip (device #1), ventralight st (device #2), and ventrio st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is only making a claim for an adverse patient outcome against the sepramesh ip (device #1) and ventralight st (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) 2012 or (b)(6) 2016, the patient underwent surgery, which included implant of the following unspecified bard/davol hernia mesh devices; sepramesh ip (device #1), ventralight st (device #2), and ventrio st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is only making a claim for an adverse patient outcome against the sepramesh ip (device #1) and ventralight st (device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per medical and plaintiff profile form: (b)(6) 2011 ¿ patient was diagnosed with small bowel obstruction and adhesion thereby underwent open repair.Per operative notes, ¿the small bowel with multiple knuckles were noted.The adhesiolysis were performed and sutured.¿ (b)(6) 2012 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with implant of sepramesh (device #1).The hernia sac was identified and contents were reduced.A piece of sepramesh (device #1) was placed and sutured." (b)(6) 2016 - patient was diagnosed with recurrent ventral incisional hernia, adhesions thereby underwent laparoscopic repair with removal of sepramesh (device #1) and implant of ventralight st using echo ps (device #2).Per operative notes, ¿the adhesions in the old mesh (device #1) and abdomen were lysed.The mesh (device #1) was pulled away from the fascia.The sepramesh was dissected free from the hernia and sutured.The ventralight st using echo ps (device #2) was placed over the defect closed and tacked.(b)(6) 2016 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of ventrio st mesh (device #3).Per operative notes, ¿ the adhesions in the right side were lysed.The hernia was identified and placed with ventrio st mesh (device #3) tacked and sutured.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventralight st using echo ps (device #2) 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: h11: this supplemental emdr is submitted to document additional information provided and to correct 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.Note, the manufacturing date (15-jan-2015) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st using echo ps(device #2).An additional emdr was submitted to represent the bard/davol sepramesh ip (device #1).The patient's attorney did not make any allegations regarding the implanted bard/davol ventrio st device (device #3).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
• 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: 9382477
• Report Number: 1213643-2019-11547
• Device Sequence Number: 19433825
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748(17)170128(10)HUZA0739
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 01/28/2017
• Device Catalogue Number: 5955610
• Device Lot Number: HUZA0739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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 Age: 65 YR
• Patient Sex: Male