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

Catalog Number	5954460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2011 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of the sepramesh ip (device #1).Per operative notes, ¿a bard sepramesh ip (device #1) was placed and sutured.¿ on (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device #2).Per operative notes, ¿hernia sac was dissected.A ventralight st mesh (device #2) was placed and sutured.¿ on (b)(6) 2014 - patient was diagnosed with post laparoscopic gastric bypass, symptomatic gred, symptomatic hiatal hernia thereby underwent open repair with removal of symptomatic hiatal hernia.On (b)(6) 2015 - patient was diagnosed with small bowel obstruction thereby underwent repair with lysis of adhesion, exploratory laparotomy.On (b)(6) 2016 - patient was diagnosed with symptomatic gerd, symptomatic hiatal hernia, recurrent incisional hernia thereby underwent robotic assisted repair with implant of the ventralight st w/ echo mesh (device #3).Per operative notes, ¿hernia sac was dissected free.A ventralight st w/ echo mesh (device #3) was placed and sutured.¿.
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-feb-2011) is considered to be a best estimate.This emdr represents the bard/davol ventralight st mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol 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 MESH
• 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: 22540276
• Report Number: 1213643-2025-00652
• Device Sequence Number: 7029490
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)130228(10)HUVB0819
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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): 07/14/2025

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: 02/28/2013
• Device Catalogue Number: 5954460
• Device Lot Number: HUVB0819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2011
• 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: 49 YR
• Patient Sex: Female