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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX MESH SURGICAL MESH Back to Search Results
Catalog Number 0010301
Device Problem Material Too Rigid or Stiff (1544)
Patient Problems Erythema (1840); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
As reported the patient has a complicated medical history and has not been evaluated by his physician regarding his reported symptoms. Based on the information available at this time, no conclusions can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental emdr will be submitted. Note: 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
It was reported that the patient was implanted with a davol ventralex mesh on (b)(6) 2006 after being involved in a motorcycle accident. Contact reports the mesh was placed above the umbilicus where the abdomen was "split open" during the accident. Recently, the patient has been feeling some regional pain and redness in the area of the mesh and that the mesh feels "hard" under the skin and he feels a "poking" sensation at times. The contact reports the patient is extremely physically fit and continues to be despite his injuries from the motorcycle accident that he states "ruined his life. " the patient's job requires him at times to lift windows that weigh up to (b)(6). The patient has not been evaluated by his doctor or returned to the implanting surgeon for follow up for treatment of the reported symptoms. However,as reported he goes to physical therapy every day following the motorcycle accident and feels pain in the abdominal area where the mesh was placed when he is undergoing pt sessions. The contact states he is not sure what is causing the pain but believes the mesh has become hardened and is poking out under the skin. The contact stated that the patient was going to seek advice from his physician, however had not scheduled an appointment at this time.
 
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Brand NameVENTRALEX 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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7610660
MDR Text Key111373414
Report Number1213643-2018-02012
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2011
Device Catalogue Number0010301
Device Lot Number43CQD535
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 Received05/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2006
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: 06/18/2018 Patient Sequence Number: 1
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