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

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Seroma (2069); Hernia (2240)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
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-aug-2018) is considered to be a best estimate.This emdr represents the bard soft mesh (device 2).An additional supplemental emdr and emdr were submitted to represent the ventralex st mesh (device 1) and ventralex mesh (device 3).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.
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per op notes, "an infraumbilical incision was made.The hernia sac was identified and mobilized.A ventralex st mesh (device 1) was placed and secured with suture." (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of ventralex st mesh (device 1) and implant of bard soft mesh (device 2).Per op notes, "a periumbilical midline incision was made.The hernia sac was identified, reduced and excised.A ventralex st mesh (device 1) was noted to be curled up and excised.A bard soft mesh (device 2) was placed and secured with sutures." (b)(6) 2020 - patient was diagnosed with recurrent incarcerated ventral incisional hernia thereby underwent open repair with implant of ventralex mesh (device 3).Per op notes, "the old scar was reopened.A large hernia sac was identified and dissected to the fascia.The sac was opened and amputated.It had incarcerated omentum within it.Another large fascial defect was noted inferiorly.The skin bridge between the two was opened and the hernia was coalesced into one hernia.A large ventralex mesh (device 3) was placed and secured with sutures." (b)(6) 2020 - patient had drainage of seroma.

• Brand Name: BARD SOFT 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: 25591403
• Report Number: 1213643-2026-00785
• Device Sequence Number: 5442636
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)230828(10)HUCV1471
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 08/28/2023
• Device Catalogue Number: 0117011
• Device Lot Number: HUCV1471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2018
• 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: Female
• Patient Weight: 99 KG