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

Catalog Number	5955600
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient¿s attorney and review of patient medical records: (b)(6) 2014 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex st mesh (device #1).Per operative notes, ¿the hernia sac was freed from the fascia and the umbilical skin tack.Then a ventralex st mesh (device #1) was placed intraabdominally and anchored it to the edge of the fascia to the edges of the mesh using sutures.¿ (b)(6) 2014 - patient was diagnosed with surgical wound infection thereby underwent open repair.Per operative notes, ¿there was a purulent old looking hematoma.The mesh (device #1) did appear to be intact, and the area of infection appeared to be minimal.¿ (b)(6) 2015 - patient was diagnosed with exposed mesh thereby underwent open repair with removal of ventralex st mesh (device #1).Per operative notes, ¿the edges of the mesh were under the fascia, the rest came through the hernia defect.There were some omental adhesions from the underside of the mesh.Then the ventralex st mesh (device #1) was removed.¿ (b)(6) 2017 - patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with the implant of ventralight st using echo ps (device #2).Per operative notes, ¿there was a significant ventral incisional hernia with omentum being stuck into it.Once the omentum and small bowel had been removed from the hernia site, a ventralight st using echo ps (device #2) was then placed into the abdomen after being sized externally.¿ attorney alleges that the patient had adhesions, infection, mesh migration, pain and hernia recurrence.It was also alleged that the mesh was exposed through the skin, mesh at the edges was under the fascia, the rest of mesh came through the hernia defect, omental adhesions at underside of the mesh, hematoma.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 3 months post implant of ventralight st using echo ps, patient was diagnosed with hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represent the bard/davol ventralight st mesh using echo ps (device #2).An additional supplemental emdr was submitted to represents the bard/davol ventralex st 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.Not returned.

• 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: 21706234
• Report Number: 1213643-2025-090140
• Device Sequence Number: 9941897
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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 Catalogue Number: 5955600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 89 KG