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

Catalog Number	5950080
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a secondary hernia repair procedure, a hair was pulled out from a ventrio st mesh pocket intraoperatively.As reported, it was assumed by the user facility that the hair was in between the posterior and anterior mesh layers.The hair was removed and the mesh remains implanted.A photo of the removed hair after being removed from the device was provided.The hair was not noted upon opening the sterile package, prior to insertion.Based on the evaluation of photo and investigation performed, no conclusion can be made as to the origin of the hair.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in june, 2019.Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.
Event or Problem Description
It was reported that a patient who had previously been implanted with a phasix mesh presented with a recurrence of the hernia.On (b)(6) 2020 the patient underwent a revision procedure to repair the recurrence.As reported, a ventrio st mesh was pulled from the hospital shelf and used for reinforcement of the recurrent hernia.The surgeon placed the ventrio st mesh in the patient and then used a non-bard/davol fixation system to place 33 tacks through the outer pocket and into the patient.While suturing the fascia to the inner pocket, the surgeon saw something and used pick-ups to pull out a (approximately) 7¿ long dark hair from the inner pocket of the mesh.After discussion with several individuals, it was assumed that the hair was in between the posterior and anterior mesh on the ventrio st, and was therefore sterilized.The hair was removed, mesh washed out, and a drain was placed in the patient to monitor output.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10507787
• Report Number: 1213643-2020-08085
• Device Sequence Number: 11547021
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 5950080
• Device Lot Number: HUDS1125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR