MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number 5991520

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seroma (2069)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

As reported, about one month post-implant of the ventralight st mesh using echo ps 2, the patient was diagnosed with abdominal wall seroma and underwent drainage.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of 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 114 units released for distribution in (b)(6) 2020.

Event Description

Reported per clinical trial (b)(4).(b)(6) 2020 - subject patient underwent an robotic assisted first time recurrent left incisional hernia (7x7 cm) repair procedure and implanted with a bard/davol ventralight st mesh using echo ps 2, in an onlay fashion intra-peritoneally.Full skin closure was achieved using sutures.The patient was discharged from the hospital on (b)(6) 2020.(b)(6) 2020 - subject patient was diagnosed with abdominal wall seroma.(b)(6) 2021- subject patient underwent an ultrasound-guided drainage of the seroma with a placement of jp suction bulb and was discharged on the same day.(b)(6) 2021 - seroma resolved.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 W/ ECHO 2
• Type of Device: 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: 14488107
• MDR Text Key: 292500412
• Report Number: 1213643-2022-00298
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 5991520
• Device Lot Number: HUDZ1864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 106 KG