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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number 0010216
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2016
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing records was performed and found that the lot was manufactured to specification. As the sample is unavailable for return the device cannot be evaluated for root cause. Based on the event as reported and not having the sample to evaluate this complaint is inconclusive. If/when additional information is obtained a supplemental mdr will be submitted.
 
Event Description
The following was reported to davol: it is reported that the patient developed an incisional hernia following a lower laparotomy combined with linea alba diastasis. As reported a bard/davol ventrio hernia patch was used to close both defects and a bard/davol sorbafix was used to fixate the mesh patch. It is reported that the surgeon noticed that the fasteners were going through the mesh in the area of the positioning pocket, tearing the mesh while the fasteners remained in the abdominal wall. As reported counter pressure was applied when fixation was being performed and the mesh was being fixated close to the outer memory ring of the ventrio patch. The surgeon used suture to complete the procedure. An ultrasound examination proved that the mesh is fixed in the proper position, no seroma formation. The patient was discharged seven days post implant with no complaints.
 
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Brand NameVENTRIO MESH
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6044779
MDR Text Key57980144
Report Number1213643-2016-00486
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Catalogue Number0010216
Device Lot NumberHUZK0192
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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