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

Catalog Number 5954680

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling/ Edema (4577)

Event Date 03/25/2013

Event Type  malfunction  

Event Description

Reported per clinical trial dvl-he-020: on 19-mar-2013 - subject patient underwent a primary laparoscopic infra-umbilical midline hernia repair procedure during which a bard/davol ventralight st mesh was implanted using bard/davol sorbafix mechanical fixation and sutures.The fascia was completely closed and full skin closure was achieved using adhesive skin closure.The subject patient was discharged from the hospital on 22-mar-2013.On 25-mar-2013 - subject patient was diagnosed with swelling over hernia repair site during the 1st post-op visit.No action taken.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 with sequelae.

Manufacturer Narrative

As reported, six days post-implant of the ventralight st mesh, the patient had swelling over the hernia repair site, 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 procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records shows product was manufactured to specification.This mdr represents the ae of swelling.Additional mdrs were submitted to represent aes of infected seroma and recurrent hernia.Device not returned.

• Brand Name: VENTRALIGHT ST MESH
• 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: 14487711
• MDR Text Key: 292502131
• Report Number: 1213643-2022-00295
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• 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: 05/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 5954680
• Device Lot Number: HUXA1446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 47 KG