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	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	07/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2014 - patient was diagnosed with ventral hernia in left lower abdominal wall thereby underwent open repair with the implant of ventrio mesh.Per operative notes, ¿the hernia sac was encountered and then opened.The small hernia above and medial was closed with sutures and a piece of ventrio mesh was placed into the defect with a smooth side down and a rough side up.¿ (b)(6) 2015 - patient was diagnosed with cellulitis and abdominal wall abscess thereby underwent incision and drainage of left lower quadrant abdominal wall abscess.(b)(6) 2015- patient was diagnosed with wound infection, infected mesh and recurrent ventral hernia thereby underwent repair with mesh removal.Per operative notes, ¿an abundant area of granulation and chronic abscess cavity was encountered.The mesh contained granulation and some purulent material.Adherent omentum with adhesions were noted.The ventrio mesh was completely excised and a piece of synthetic mesh was placed and sutured.¿ attorney alleges that the patient had abscess, adhesions, pain, infection, hernia recurrence and emotional injuries.It is also alleged that the patient had stress, anxiety, permanent physical limitations in regard to exercise and physical scaring.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 9 months post implant of ventrio mesh, patient was diagnosed with abscess, hernia recurrence, cellulitis, granuloma, bacterial infection and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list adhesions, hernia recurrence and infection as possible complications.The warning section of the 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." review of the manufacturing records was performed and found that the lot was manufactured to specification.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.H3 other text : not returned.

• 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: 14139996
• Report Number: 1213643-2022-93218
• Device Sequence Number: 6311436
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 04/28/2015
• Device Catalogue Number: 0010211
• Device Lot Number: HUWD1224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• 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; Disability
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 105 KG