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

Catalog Number	5954124
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, about 3 weeks post-implant of the ventralight st mesh, the patient was diagnosed with seroma, 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 conclusion can be made.Seroma is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists seroma as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2018.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2018: subject patient underwent a primary midline open hernia (20x30 cm) repair procedure and was implanted with a bard/davol ventralight st mesh.The fascia was completely closed and full skin closure was achieved using staples and sutures.The patient was discharged from the hospital on (b)(6) 2018.On (b)(6) 2018: subject patient was diagnosed with seroma.No treatment given.By the next appointment on (b)(6) 2018, the seroma was no longer noted.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• 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: 14437998
• Report Number: 1213643-2022-00240
• Device Sequence Number: 14886246
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/10/2022

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: 07/28/2020
• Device Catalogue Number: 5954124
• Device Lot Number: HUCU0508
• 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: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2018
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG