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

Catalog Number UNKAA077

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Seroma (2069); Fluid Discharge (2686)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided no conclusions can be made.As reported, the patient developed a seroma post implant of the ventralex mesh.Seroma formation 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.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event and date of implant are estimated based on the information available.Should additional information is provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

As reported, the patient underwent bowel anastomosis repair and ileostomy takedown ¿about 23 days ago¿ ((b)(6) 2021.) it was reported that the surgeon was unable to close the wound and used a bard/davol ventralex mesh as an onlay.Following this procedure the patient developed a seroma which was draining through a small skin opening.As reported, the patient is doing fine now.

• Brand Name: MESH VENTRALEX
• 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: 12623384
• MDR Text Key: 276126431
• Report Number: 1213643-2021-20358
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• 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): Required Intervention