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

Catalog Number	5954450
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 2 years, 2 months post implant of ventralight st mesh, patient was diagnosed with hernia recurrence.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-apr-2013) is considered to be a best estimate.This emdr represents ventralight st mesh (device #6).An additional supplemental emdr's were submitted to represent ventrio mesh (device #1 & #2) and composix l/p mesh (device #3).Additional emdr's was submitted to represent ventralight st meshes (device #4 & #5).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
Per information provided: (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio mesh (device #2).Per operative notes, ¿the scar was excised.The fascia and hernia defect were dissected free.Adhesions were taken down from the anterior abdominal wall.A ventrio mesh (device #1) was placed deep to fascia, but it could not laid flat and continuing to buckle over, was removed.Thus, a ventrio mesh (device #2) was placed and secured to the abdominal wall using tacks.¿ (b)(6) 2011 - patient had abdominal pain and was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant composix l/p using echo ps (device #3).Per operative notes, ¿a midline abdominal wall defect just above the level of the umbilicus was noted.There was some colon adherent to the right lateral edge of the hernia.Adhesions of omentum and colon were taken down.The attachments to the hernia sac and posterior aspect of the anterior abdominal wall were taken down up to the level of the superior edge of the previously placed mesh (device #2).The composix l/p using echo ps (device #3) was positioned against posterior aspect of abdominal wall and secured circumferentially using sorbafix protacker.¿ (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the removal of meshes (device #2, #3) and implant of ventralight st mesh (device #4).Per operative notes, ¿the anterior abdominal wall was dissected where omentum was adherent.Two previously placed pieces of mesh were noted and the recurrent hernia was at the junction of meshes.The old meshes (device #2, #3) were removed the hernia defect was repaired using ventralight st mesh (device #4) and secured to abdominal wall using tacks.¿ (b)(6) 2013 - patient was diagnosed with ventral hernia and two right incisional hernia thereby underwent laparoscopic repair with implant of two ventralight st meshes (device #5, #6).Per operative notes, ¿the adhesions of omentum and colon in the midline were lysed.The herniated contents were reduced.There were 2 defects on the right side.The defect was centrally of partial eventration of mesh (device #4) into previous hernia defect.Two ventralight st mesh (device #5, #6) was positioned at the center of each hernia defect and secured to abdominal wall using absorbable tacks.¿ attorney alleged that the patient had adhesions, pain and hernia recurrence.

• Brand Name: VENTRALIGHT ST MESH
• 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: 21759630
• Report Number: 1213643-2025-090145
• Device Sequence Number: 15656334
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)150428(10)HUXD1348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 04/28/2015
• Device Catalogue Number: 5954450
• Device Lot Number: HUXD1348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 122 KG