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

Catalog Number	0117016
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2011 - patient was diagnosed with three incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #1).Per operative notes, "the scarred subcutaneous adipose tissue to a large hernia sac with two hernias were noted.The fascial bridge connecting the hernias was opened converting into a single hernia.The fascial edges were freed and adherent omentum was taken down.A ventralex patch (device #1) was placed in fascial tissue plane and sutured.Another fascial defect was closed primarily.The defect was closed on top of the patch." (b)(6) 2012 - patient had symptomatic gall stones thereby underwent laparoscopic cholecystectomy.(b)(6) 2015 - patient was diagnosed with large recurrent midline incisional hernia with intrabdominal adhesions and partial small bowel obstruction thereby underwent open repair with the explant of ventralex (device #1) and implant of bard soft mesh (device #2) and xenmatrix ab (device #3).Per operative notes, "the prior mesh (device #1) had pulled loose from surrounding fascia and was excised.Adhesions were noted to the small bowel both proximally and distally, fairly adherent in pelvis.Adhesiolysis was performed.A portion of omentum was resected.The extra muscle separation was noted from xiphoid down to pubic area.Component separation was performed.The central potion of posterior fascia had a large space and was closed with xenmatrix ab (device #3) was cut into oval placed and sutured.The bard soft mesh (device #2) was placed in retrorectus space and sutured." (b)(6) 2016 - patient was diagnosed with left abdominal wall hematoma/seroma thereby underwent ultrasound guided aspiration of abdominal wall fluid collection.Per operative notes, "area of soft tissue containing multiple septations and minimal fluid was noted.The serous fluid were obtained." attorney alleged that the patient had adhesions, bowel obstruction, mesh migration, pain, hernia recurrence and emotional injuries.It was also alleged that patient had complications urinating due to adhesion damage.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 1 month post implant of bard soft mesh, patient was diagnosed with seroma thereby underwent additional surgery.The instructions-for-use supplied with the device list seroma 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-feb-2015) is considered to be a best estimate.This emdr represents the bard soft mesh (device #2).An additional emdr was submitted to represent the xenmatrix ab (device #3) and additional supplemental emdr was submitted to represent the mesh ¿ ventralex ( 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: BARD SOFT 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: 21362608
• Report Number: 1213643-2025-090073
• Device Sequence Number: 8435177
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)200228(10)HUZB0223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 02/28/2020
• Device Catalogue Number: 0117016
• Device Lot Number: HUZB0223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2015
• 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: 53 YR
• Patient Sex: Male