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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH; SURGICAL MESH Back to Search Results
Catalog Number UNKAA078
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Multiple attempts have been made to contact both the hospital contact and the surgeon to request additional information.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.As reported the mesh remains implanted.Based on the limited information that has been provided to date and not having the sample for review, no definitive conclusions can be made at this time.Should additional information be obtained, a supplemental mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.
 
Event Description
The following was reported to davol: it has been reported that during a case, after tacking the ventralight st hernia patch into place the surgeon thought there may have been holes in the mesh.The surgeon completed the case, but later had concern about how this would affect the patient.
 
Manufacturer Narrative
This is an addendum to the initial mdr as additional information and intraoperative photos have been provided.The images provided show areas of material separation of the st coating.It is possible that portions of the coating were wet and stuck together and when the surgeon separated the sections of st coating this caused the material separation as shown in the images.Our instructions-for-use, supplied with the device recommends that the mesh "be completely immersed in sterile saline for no more than 1-3 seconds immediately prior to placement in order to maximize flexibility of the prosthesis." device remains implanted.
 
Event Description
The following was reported to davol: it has been reported that during a case, after tacking the ventralight st hernia patch into place the surgeon thought there may have been holes in the mesh.The surgeon completed the case, but later had concern about how this would affect the patient.Addendum per follow up with the surgeon: the surgeon reported that he has recently been using davol mesh.The mesh was placed in an open umbilical procedure.It was not hydrated prior to insertion.Trans facial sutures were placed north and south, the mesh loosely rolled per recommended method.He stated that he did note the mesh had stuck together and he had to separated it, but did not note any defects at that time.After fastening the mesh he noted 3 areas where it appeared that the st coating had come off.He said these were fairly large areas.At this point he did not want to remove the mesh due to the trauma that could present to the tissue.He reports the patient has not reported any post-op complications at this time but that he is monitoring her progress.
 
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Brand Name
VENTRALIGHT ST MESH
Type of Device
SURGICAL 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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5846244
MDR Text Key51143704
Report Number1213643-2016-00371
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKAA078
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received08/09/2016
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 Number1
Patient Age36 YR
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