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

Catalog Number	5954810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, post-implant of the ventralight st mesh, the patient was diagnosed with seroma, which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusions can be made.Seroma formation is a known inherent risk of the surgery and included as a possible complication in the adverse reactions section of the instructions-for-use supplied with the device.To date, this is the only reported complaint for this manufacturing lot.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial: on (b)(6) 2017: subject patient underwent primary laparoscopic midline infraumbilical hernia repair procedure.A bard/davol ventralight st mesh was placed in underlay fashion intra-peritoneally using a mechanical fixation device and suture.Full skin closure was achieved with sutures and adhesive skin closure.The patient was discharged to home on (b)(6) 2017.On (b)(6) 2017: subject patient was diagnosed with seroma which resolved on (b)(6) 2018.No action taken.This ae is clinically assessed to be possibly related to the study device and definitely related to the procedure.This has been assessed as a non-serious adverse event of mild severity and has resolved.The reported adverse event does not meet the definition of a sae (serious adverse event).

• Brand Name: VENTRALIGHT ST 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: 14457345
• Report Number: 1213643-2022-00254
• Device Sequence Number: 4482501
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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: 03/28/2019
• Device Catalogue Number: 5954810
• Device Lot Number: HUBQ1844
• 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: 05/20/2022
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 105 KG