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

Catalog Number	5955450
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per information provided: 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-oct-2020) is considered to be a best estimate.This emdr represents the ventralight st mesh using echo ps (device #2).An additional supplemental emdr was submitted to represent the bard flat mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2020 - patient was diagnosed with incisional hernia at right upper quadrant thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, "the hernia was identified lateral to rectus.The fascia was closed and a bard flat mesh (device #1) was placed and sutured." (b)(6) 2021 - patient was incisional hernia without obstruction and adhesions thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device #2).Per operative notes, "a palpable region of fascial weakness in right upper quadrant was noted.A ventralight st mesh using echo ps (device #2) was placed and tacked." (note: there was no mention/visualization of the previously placed bard flat mesh (device #1) during this procedure) (b)(6) 2022 - patient was diagnosed with recurrent ventral incisional hernia at right upper quadrant and scar tissue thereby underwent open repair with the implant of phasix st mesh (device #3).Per operative notes, "the edge of a previous mesh (device #2) repair was seen.The hernia was just inferior edge of this.A phasix st mesh (device #3) was sutured.".

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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 ; 4018258495
• MDR Report Key: 21965577
• Report Number: 1213643-2025-090202
• Device Sequence Number: 12870842
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717(17)220928(10)HUEX0988
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 09/28/2022
• Device Catalogue Number: 5955450
• Device Lot Number: HUEX0988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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