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

Catalog Number	5950009
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	10/12/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with incisional hernia x2 thereby underwent open repair with implant of ventralex st (device #1 & #2).Per operative notes, ¿the first hernia defect was identified and reduced.A large ventralex st (device #1) was placed and sutured.The 2nd inferior defect was identified and repaired with medium sized ventralex st (device #2)".(b)(6) 2012 - patient was diagnosed with gastric outlet obstruction with stricture of gastroduodenal thereby underwent open repair with excision of mesh (device #1).Per operative notes, ¿the adhesions of omentum and bowel with mesh were lysed.The balled up large ventralex st (device #1) was removed and stricturoplasty was performed.(b)(6) 2014 - patient was diagnosed with chronic wound drainage and infection thereby underwent open repair with partial excision of mesh (device #2).Per operative notes, ¿the chronic sinus tract was removed.The mesh (device #2) with purulence was partially removed.(b)(6) 2015 - patient was diagnosed with recurrent incisional hernia x2 thereby underwent open repair with implant of ventralex st (device #3 & #4).Per operative notes, ¿the small hernia defect was identified and repaired with small ventralex st (device #3).The large hernia defect was identified and repaired with ventralex st (device #4).
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-jul-2012) is considered to be a best estimate.This emdr represents the ventralex st (device #1).An additional supplemental emdr was submitted to represent the ventralex st (device #2).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: 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: 22139603
• Report Number: 1213643-2025-00429
• Device Sequence Number: 20588840
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)140728(10)HUWG0003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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: 07/28/2014
• Device Catalogue Number: 5950009
• Device Lot Number: HUWG0003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2012
• 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: 39 YR
• Patient Sex: Female