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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problems Material Disintegration (1177); Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Pain (1994); Hernia (2240)
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative
No conclusion can be made. The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge. " however, at this time, based on the information provided, a cause for the reported patient condition has not been determined. Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication. A lot number was not provided, without a lot number a review of the manufacturing records is not possible. Note the date of implant is estimated based on the information provided as an exact date of implant was not reported. Should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
 
Event Description
It was reported that in (b)(6) 2017 the patient underwent hernia repair with the implant of a bard/davol ventralex st mesh. As reported, the patient subsequently experienced a wound dehiscence, a bulge at the area of the initial repair and chronic pain. As reported at times the pain prevents the patient from walking around. The contact reports that the patient's current surgeon, who assessed the issues has indicated that "it appears the defect was not sufficiently closed during the initial procedure, which may have led to the budge. " the contact reports that the patient will undergo an additional surgery, however has not provided any specific timeframe or date in which this will take place.
 
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Brand NameVENTRALEX 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 Key8584244
MDR Text Key144241622
Report Number1213643-2019-03644
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5950008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2020
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 Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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