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

Catalog Number	5954113
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, prior to attempted implant, the ventralight st mesh was hydrated significantly longer than the ifu recommends using normal saline and gentamicin solution.The preparations section of the instructions-for-use (ifu) supplied with the device states, "ventralight st mesh be completely immersed in sterile saline for no more than 1-3 seconds immediately prior to placement.¿ and ¿the safety and effectiveness of ventralight st mesh in combination with solutions other than saline have not been tested.¿ the mesh was implanted into the patient and not available for review.Based on the information provided the most probable root cause is that the reported event is the result of the user hydrating the mesh longer than the ifu recommended 1-3 seconds.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september, 2020.Not returned - remains implanted.
Event or Problem Description
As reported, during a hernia repair procedure on (b)(6) 2022, the bard/davol ventralight st mesh was hydrated twice in a normal saline and gentamicin solution for significantly longer than the ifu recommended 1-3 seconds.As reported, the mesh "oozed green gel-like substance" during fixation.It was reported that the surgeon implanted the same mesh without any other disturbance.There was no reported patient injury.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: 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: 13651609
• Report Number: 1213643-2022-00039
• Device Sequence Number: 17626432
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: 5954113
• Device Lot Number: HUEU1098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown