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

Catalog Number	5955810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011 - patient was diagnosed with ventral hernia thereby underwent repair with implant of ventralex mesh (device 1).(note: no operative note is available in the mrr for this procedure.) (b)(6) 2012 - patient was diagnosed with recurrent umbilical hernia, pain, adhesion thereby underwent laparoscopic repair with explant of ventralex mesh (device 1) and implant of sepramesh ip (device 2).Per operative notes, "an incision was made into the umbilical region.The hernia sac was dissected out.There were some adhesions that were to the previously placed mesh.All adhesions were taken down sharply.The previously placed (device 1) mesh was buckled at one point.Old (device 1) was removed from the abdominal wall.A sepramesh ip (device 2) was placed into the abdomen and secured it with sutures." (b)(6) 2016 - patient was diagnosed with recurrent umbilical hernia, pain, adhesion thereby underwent laparoscopic repair with explant sepramesh ip (device 2) and implant of ventralight st w/ echo mesh (device 3).Per operative notes, "a midline incision was made overlying the hernia through the subcutaneous tissue.The hernia sac was dissected out.There were dense adhesions throughout the abdomen.There were dense adhesions to the anterior abdominal wall.All adhesions were taken down sharply.Previously placed (device 2) had torn out and free from the right side.Old mesh (device 2) was removed.A ventralight st w/ echo mesh (device 3) was placed into the abdomen and secured it with sutures." (b)(6) 2018 - patient was diagnosed with hernia thereby underwent repair with removal of ventralight st w/ echo mesh (device 3) and implant of sepramesh ip (device 5).(note: no operative note is available in the mrr for this procedure.).
Additional Manufacturer Narrative
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.This emdr represents the ventralight st w/ echo mesh (device 3).An additional supplemental emdr and emdr were submitted to represent the sepramesh ip (device 2) and ventralex mesh (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.

• 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 ; 8005566756
• MDR Report Key: 25678169
• Report Number: 1213643-2026-00839
• Device Sequence Number: 18572561
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786(17)170928(10)HUZH2442
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 09/28/2017
• Device Catalogue Number: 5955810
• Device Lot Number: HUZH2442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2015
• 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: 43 YR
• Patient Sex: Male