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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO SURGICAL MESH Back to Search Results
Model Number 0010219
Device Problem Defective Device (2588)
Patient Problems Unspecified Infection (1930); Pain (1994); Disability (2371)
Event Date 09/19/2013
Event Type  Injury  
Manufacturer Narrative
Addendum to the previous information. This supplemental emdr is being sent to correct the date of event. A review of the manufacturing records was conducted which found that the device provided was manufactured to specification. With the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.
 
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided it is alleged the patient experienced infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ if additional event and/or evaluation information is obtained, a follow up 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. Not returned to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2013 - the patient underwent surgery for repair of an incisional ventral hernia, a ventrio hernia mesh was implanted to repair the hernia defect. On (b)(6) 2013 - the patient underwent an additional surgery to remove infected mesh. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.
 
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Brand NameVENTRIO
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7153869
MDR Text Key262912309
Report Number1213643-2017-01135
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2015
Device Model Number0010219
Device Catalogue Number0010219
Device Lot NumberHUWL1152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/28/2012
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: 12/29/2017 Patient Sequence Number: 1
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