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

Catalog Number	5955790
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	08/20/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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 mesh (device #1).An additional emdr was submitted to represent the bard/davol ventralight st mesh (device #2).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 two unspecified bard/davol ventralight st on (b)(6) 2014 and (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient sustained injuries on (b)(6) 2014 and (b)(6) 2015.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." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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.H11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510(k) 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-oct-2010) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b6, b7, d3, d.6b (date of explant), g3, g4, g6, h2, h4, h6, h10, h11.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 two unspecified bard/davol ventralight st on (b)(6) 2014 and (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient sustained injuries on (b)(6) 2014 and (b)(6) 2015.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2014 ¿ patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of two ventralight st using echo ps (device 1 and 2).Per operative notes, ¿ventral hernia with large defect and some adhesions of omentum to abdominal wall was noted.The sac and adhesions were reduced and two ventralight st using echo ps (device 1 and 2) meshes were placed within the hernia defect against abdominal wall and tacked circumferentially.¿ (b)(6) 2014 - patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with partial removal of meshes (device 1 and 2).Per operative notes, ¿the hernia defect with folded meshes (device 1 and 2) were identified.The adhesions to greater omentum was lysed.The segment of meshes (device 1 and 2) were removed and hernia defect with scar was closed with sutures.¿ (b)(6) 2015 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 3).Per operative notes, ¿adhesions of anterior abdominal wall was lysed.The recurrent hernia with old meshes (device 1 and 2) was seen slipped into hernia around circumference.The meshes (device 1 and 2) were tacked and hernia defect was repaired with ventralight st using echo ps (device 3) and 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: 11286617
• Report Number: 1213643-2021-00830
• Device Sequence Number: 11723893
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(17)141028(10)HUWJ0761
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 10/28/2014
• Device Catalogue Number: 5955790
• Device Lot Number: HUWJ0761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2012
• 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: 62 YR
• Patient Sex: Female