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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Seroma (2069); Hernia (2240); Drug Resistant Bacterial Infection (4553)
Date of Event	10/02/2015
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-mar-2015) is considered to be a best estimate.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 by patient¿s attorney and review of patient medical records: attorney alleges per short form that the patient underwent surgery for implant of an unspecified bard/davol ventralex st on (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against ventralight st.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient, experienced emotional distress and the device was defective.(b)(6) 2015 ¿ patient was diagnosed with chronic cholecystitis, adhesions, umbilical hernia thereby underwent laparoscopic repair with the implant of ventralex st mesh (device #1).Per operative notes, ¿the gallbladder is removed.The hernia sac was excised.A medium ventralex st mesh (device #1) was placed in the defect using sutures.¿ (b)(6) 2015 ¿ patient had seroma and diagnosed with infected mesh, large recurrent umbilical hernia thereby underwent laparoscopic repair with the removal of ventralex st mesh (device #1) and an implant of xenmatrix ab mesh (device #2).Per operative notes, ¿seroma was aspirated.A minimal intraabdominal adhesion from omentum to the periumbilical area, extraperitoneal mesh were lysed.The ventralex st mesh (device #1) was excised completely.A xenmatrix ab mesh (device #2) was placed through the umbilical defect and fixated using capsure staplers.¿.

• Brand Name: VENTRALEX ST
• 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: 22737815
• Report Number: 1213643-2025-00733
• Device Sequence Number: 7125612
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)170328(10)HUZC0585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 03/28/2017
• Device Catalogue Number: 5950008
• Device Lot Number: HUZC0585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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: 61 YR
• Patient Sex: Female