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

Catalog Number 5954810

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

As reported, the implanted ventralight st mesh tore from the surgical site. It is unclear at this time what symptoms the patient experience and what treatment was provided. The information provided is limited to the maude event report. Contact information was not provided, as such we are unable to request additional information. Based on the information available at this time, no conclusions can be made. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental mdr will be submitted. Not returned.

Event Description

The following was reported via maude event report (mw5097358) alleging adverse outcomes against ventralight st: "implanted ventralight st mesh tore from original surgical site. ".

• 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: 10842638
• MDR Text Key: 216317846
• Report Number: 1213643-2020-20045
• Device Sequence Number: 1
• Product Code: FTL
• 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: health professional,other,use
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 5954810
• Device Lot Number: HUCN0230
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/16/2020 Patient Sequence Number: 1