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

Catalog Number	0010211
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069)
Date of Event	11/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, about six days post-implant of the ventrio mesh, the patient developed a collection possibly representing a hematoma and seroma.No action taken and the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.The reported adverse reactions seroma and hematoma formation are known inherent risks of surgery.The adverse reactions section of the instructions-for-use supplied with the device lists seroma and hematoma as possible complications.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6) : on (b)(6) 2017 - subject patient underwent primary open midline incisional hernia repair at the right upper quadrant (ruq).A bard/davol ventrio hernia patch was implanted using mechanical fixation and sutures.The patient was discharged to home on (b)(6) 2017.On (b)(6) 2017 - subject patient developed small collection possibly representing hematoma and seroma.Per the study clinician, the reported adverse event has been assessed as mild in severity, definitely related to the study device and definitely related to the procedure.There has been no action taken at this time and the outcome for this ae is reported as recovered/resolved.

• 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: 14468984
• Report Number: 1213643-2022-00281
• Device Sequence Number: 4596865
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387
• 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: 2017
• 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): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 0010211
• Device Lot Number: HUAU0190
• 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: 05/23/2022
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 89 KG