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

Catalog Number 5954113

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Reported per clinical trial(b)(4): (b)(6) 2013 - subject patient underwent laparoscopic midline hernia repair (24cm x 14cm) procedure during which a bard/davol ventralight st mesh was implanted with suture.Full skin closure was achieved using adhesive skin closure.The patient was discharged to home on (b)(6) 2013.It was noted that the subject experienced abdominal pain at every follow-up after the procedure.(b)(6) 2015 - subject patient presented with abdominal pain and diagnosed with adhesions and underwent exploratory laparoscopic surgery for lysis of adhesions.The patient discharged from the hospital on (b)(6) 2015.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device, definitely related to the procedure.The outcome for this ae is reported has recovered/resolved.

Manufacturer Narrative

As reported, about twenty months post-implant of the ventralight st mesh, the patient was diagnosed with abdominal pain and adhesions and underwent surgery for lysis of adhesions.As reported, the ae has resolved.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.Adhesions is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists adhesions as a possible complication.To date, this is the only reported complaint for this manufacturing lot.Not returned - remains implanted.

• 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: 14490040
• MDR Text Key: 293455790
• Report Number: 1213643-2022-00316
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595
• 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: 05/10/2022

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: 06/28/2015
• Device Catalogue Number: 5954113
• Device Lot Number: HUXF0496
• 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
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 111 KG