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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with incarcerated ventral incisional hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿at the level of the umbilicus, a large ventral hernia was identified, and two smaller hernias were identified superior to this.The hernia was dissected free, and the two upper hernias were also dissected.A large perfix plug (device #1) was placed and sutured.¿ (b)(6) 2016 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with division of adhesions, removal of perfix plug (device #1) and implant of ventrio mesh (device #2).Per operative notes, ¿hernia just above the umbilicus and non recurrent hernia was identified.Both were dissected free.The entire area of the mesh (device #1) and previously involved fascia was excised.A ventrio mesh (device #2) was placed and sutured.¿ (b)(6) 2016 - patient was diagnosed with mesh infection thereby underwent open repair with the removal of ventrio mesh (device #2).Per operative notes, ¿on entering the wound, a small amount of serous fluid was encountered, and the mesh was identified.This was involved in the center portion of the mesh with an obvious infective inflammatory process.The inferior edge of the mesh was dissected free from fascia.The entire mesh (device #2) was removed.A biological mesh was placed and sutured.¿ attorney alleged that the patient had adhesions, bowel/intestinal obstruction, hernia recurrence, infection, constipation episodes, chronic pain and suffering.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about one month post implant of ventrio mesh, patient was diagnosed with infection, seroma thereby underwent repair with mesh removal.The adverse reaction section of the instructions-for-use, supplied with the device list seroma as a possible complication.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." this emdr represents ventrio mesh (device #2).An additional supplemental emdr has been submitted to represent perfix plug (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.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 20288692
• Report Number: 1213643-2024-094716
• Device Sequence Number: 8086003
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)190328(10)HUZH2327
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 03/28/2019
• Device Catalogue Number: 0010211
• Device Lot Number: HUZH2327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/24/2024
• 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: 65 YR
• Patient Sex: Female