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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST SURGICAL MESH Back to Search Results
Catalog Number 5950080
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Injury (2348)
Event Date 08/24/2020
Event Type  Injury  
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 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.
 
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Brand NameVENTRIO ST
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
4018258495
MDR Report Key10507787
MDR Text Key206128835
Report Number1213643-2020-08085
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Catalogue Number5950080
Device Lot NumberHUDS1125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2019
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: 09/09/2020 Patient Sequence Number: 1
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