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

Catalog Number	5955610
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 to what extent the bard/davol ventralight st(device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention; however no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventralight st (device #2).An additional emdr was submitted to represent the bard/davol perfix plug (device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) on (b)(6) 2014.As reported, the patient underwent surgery in which an unspecified bard/davol ventralight st (device #2) was implanted on (b)(6) 2014.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol perfix plug (device #1) and ventralight st (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventralight st (device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and product 510k number.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-apr-2014) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d4, g1, g3, g6, h2, h4, h6, h10.Corrected fields: d1 (brand name), g4 (pma/510(k)).This supplemental emdr represents the bard/davol ventralight st w/ echo (device 2).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) on (b)(6) 2014.As reported, the patient underwent surgery in which an unspecified bard/davol ventralight st (device #2) was implanted on (b)(6) 2014.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol perfix plug (device #1) and ventralight st (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2014 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of perfix plug (device 1).Per operative notes, ¿a medium perfix plug (device 1) was put in the defect and kept in place using sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the removal of mesh (device #1) and implant of ventralight st using echo ps (device #2).Per operative notes, ¿adhesion of the omentum was divided away from the abdominal wall and all mesh (device #1) was excised.A ventralight st using echo ps (device #2) was placed in center of defect using sutures.¿.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 8617349
• Report Number: 1213643-2019-03993
• Device Sequence Number: 2220379
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748(17)160428(10)HUYD0804
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 04/28/2016
• Device Catalogue Number: 5955610
• Device Lot Number: HUYD0804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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
• Patient Sex: Female