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

Catalog Number 5955460

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, there was a gelatin like substance on the polypropylene side of the ventralight st mesh with echo ps after insertion.There was no reported patient harm/injury as a result of the reported issue.The subject device remains implanted and is not available for evaluation.Based on the available information, we are unable to determine a definitive root cause for the reported event.While no determination can be made, based on the described greenish jelly material, it is possible this material was some residual st material that following hydration may have been observed on the implant.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in june, 2019.Should additional information be provided, a supplemental mdr will be submitted.

Event Description

As reported, on (b)(6) 2020, the patient was implanted with ventralight st mesh with echo ps 4"x6" ellipse during a laparoscopic spigelian hernia repair.The visual inspection of the mesh prior to insertion showed with no evidence of abnormality.Prior to insertion, the ventralight st mesh was hydrated as directed, about 1-3 seconds and was positioned using the echo balloon without any issue.As reported, once the mesh was inserted and the surgeon started to fixate the mesh, a greenish color gelatin (jelly) like substance was noted on the polypropylene side of the mesh.A surgical sponge was used to absorb some of the material in the cavity and scant amounts of the viscous material were present.Irrigation of the cavity was done at the end of the case and the discoloration was no longer observed.As reported, the surgeon did not feel there was any void to the sepra coating on the mesh.There was no reported patient harm/injury as a result of the reported issue.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 10895463
• MDR Text Key: 218192543
• Report Number: 1213643-2020-20050
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5955460
• Device Lot Number: HUDR2209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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