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

Catalog Number	5955680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Necrosis (1971); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	05/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2002 - patient was diagnosed with symptomatic umbilical hernia thereby underwent open repair with implant of composix mesh (device #1).Per operative notes, ¿the incarcerated hernia was opened and excised.Joined two hernias close to each other and a composix mesh (device #1) was affixed to the fascia peripherally using sutures.¿ on (b)(6) 2010 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with removal of mesh (device #1).Per operative notes, ¿the hernia sac was incised and adhesions were lysed.A bilayer type of mesh (device #1) with polyp properly inside which was adherent to the anterior abdominal wall was folded over where the small bowel was adherent.The remainder of the mesh (device #1) was excised completely and a piece of biological mesh was placed.¿ on (b)(6) 2011 - patient was diagnosed with multiple recurrent incisional hernia thereby underwent laparoscopic repair with implant of a biological mesh.On (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh using echo ps (device #2).Per operative notes, ¿all adhesions were taken down and the hernia defect is seen in the middle of the upper portion of the graft.A ventralight st mesh using echo ps (device #2) was introduced into the abdominal cavity and secured with sutures.¿ on (b)(6) 2017 - patient was admitted to hospital for ischemic necrosis of small bowel and bowel obstruction status post exploratory laparotomy for bowel dissection and was discharged on (b)(6) 2017.(note, no op-notes provided) attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, bowel removal, mesh migration, nerve damage, hernia recurrence, multiple revision surgeries to remove the mesh, repair of recurrent hernia and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 5 years 5 months post implant of ventralight st mesh using echo ps, patient was diagnosed with obstruction, hernia recurrence and necrosis thereby underwent revision surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.Review of manufacturing records shows product was manufactured to specification.Note, the manufacturing date (15-nov-2011) is considered to be a best estimate.This emdr represents the ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represent the mesh ¿ composix (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.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 21102311
• Report Number: 1213643-2024-094871
• Device Sequence Number: 13047966
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)121128(10)HUVK1312
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 11/28/2012
• Device Catalogue Number: 5955680
• Device Lot Number: HUVK1312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 104 KG