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

Catalog Number	0010215
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2013 - subject patient underwent a primary open midline umbilical hernia repair procedure.The size of the hernia defect was 4cm x 1cm.A bard/davol ventrio hernia patch was placed midline in an underlay fashion using intra-peritoneal placement using non-bard/davol mechanical staples and sutures.Full skin closure was achieved using staples.The patient was discharged on same day.(b)(6) 2015 - a ct scan was performed and diagnosed the patient with a recurrent incarcerated incisional ventral hernia.(b)(6) 2015 - subject patient was confirmed with recurrent hernia during physical examination.(b)(6) 2015 - subject patient underwent a upper midline incisional hernia repair for hernia recurrence and was implanted with a bard/davol ventralex hernia patch.An upper midline incision was made in the abdominal region and the suturing was made using both prolene and in a interrupted stitch and the skin was fully closed.Per the study clinician, the reported adverse event has been assessed as severe, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about 1.7 years post-implant of ventrio mesh, the patient was diagnosed with recurrent incarcerated incisional ventral hernia for which patient underwent surgical intervention.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and possibly related to the index procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.To date, there have been no other reported complaints for this lot number.Not returned - remains implanted.

• Brand Name: VENTRIO MESH
• 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: 14496475
• Report Number: 1213643-2022-00336
• Device Sequence Number: 12161189
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 09/28/2015
• Device Catalogue Number: 0010215
• Device Lot Number: HUWI0695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 88 KG