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

Catalog Number	5955610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hernia (2240)
Date of Event	11/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 ¿ patient was diagnosed with recurrent abdominal wall hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device #1).Per operative notes, ¿the defect was circular in orientation just near the umbilicus.The sepramesh ip (device #1) was placed and tacked.¿ on (b)(6) 2016 ¿ patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st with echo (device #2) and ventralight st with echo (device # 3).Per operative notes, ¿there were extensive small bowel and omental adhesions to the previous mesh near the umbilicus.There were two additional smaller hernias, one just cephalad to the main hernia, and one in the epigastrium.These are both incisional hernias.The lysis of adhesions from the small bowel to the lower larger hernia mesh was extremely difficult with the mesh (device # 1) having been fused to the small bowel extensively, up into the hernia sac.Adhesions were lysed and small bowel resection was performed.The hernia was repaired using ventralight st with echo (device # 2) and ventralight st with echo (device #3).One mesh was placed above, and another mesh was placed below to cover both hernias equally.Then, meshes were tacked circumferentially.On (b)(6) 2016 ¿ patient developed intra-peritoneal hemorrhage, acute blood loss anemia, acute kidney injury thereby underwent exploratory laparotomy, evacuation of hemoperitoneum, excision of hernia sac and explantation of laparoscopically placed mesh (device 2).Per operative notes, ¿patient became hypotensive peritoneal with leukocytosis and had drop in hemoglobin, transferred to icu in critical condition where patient was resuscitated.Large amounts of blood and blood clots were expressed, resected the hernia sac and explanted the large piece of mesh (device # 2) removing suture and tacks, evacuated 4500 cc of blood and clots, started packing and evaluating the anastomosis which looked intact.Noticed some oozing in the mesentery posterior to the anastomosis, opened the sutured mesenteric defect, found a small mesenteric bleed that was slowly bleeding and this was ligated.The patient was incubated in a critical condition and transferred to the icu.¿ on (b)(6) 2016 ¿ patient had open wound of abdomen thereby underwent washout and partial fascial closure with wound vac exchange.Per operative notes, ¿the previous abthera removed, no bleeding noted.Then, irrigated and washed between the loop of small bowel.The rest of the bowel was then inspected again and then proceeded with partial fascial closure.¿ on (b)(6) 2016 ¿ patient had open abdominal wall wound, recurrent incisional hernia thereby underwent laparotomy, explantation of old mesh and placement of phasix flat mesh (device # 4).Per operative notes, ¿the previous abthera removed, no bleeding noted.Then, irrigated and washed between the loop of small bowel.The previous remnant of the old mesh at the lower aspect of the abdomen was explanted (device #1 # 3), the previous fascial stitches were removed.The phasix flat mesh (device #4) was placed.¿.
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.Note, the manufacturing date (15-sep-2015) is considered to be a best estimate.This mdr represents the ventralight st w/echo (device 2).An additional mdr will be submitted for ventralight st with echo (device 3) and another supplemental emdr was submitted to represent the sepramesh ip (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: 23730443
• Report Number: 1213643-2025-01174
• Device Sequence Number: 13410213
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748(17)171028(10)HUZI1922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: 10/28/2017
• Device Catalogue Number: 5955610
• Device Lot Number: HUZI1922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female