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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010302
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Inflammation (1932); Pain (1994); Hernia (2240); Insufficient Information (4580)
Event Date 02/06/2015
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, chronic pain, and revision surgery. The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that on or about (b)(6) 2013, the patient underwent repair of an abdominal hernia and was implanted with a bard/davol ventralex mesh and a non-bard mesh. It is alleged that "as a direct and proximate result of defendants¿ defective design, manufacture, marketing, distribution, and/or sale of the ventralex and proceed and placing the defective product into the stream of commerce, the patient has been injured and damaged as follows": on or about (b)(6) 2015, the patient underwent revision of the ventralex mesh and the non bard/davol mesh. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, mesh detachment, mesh reinforcement, and recurrence. It is alleged that the patient continues to suffer complications as a result of implantation with the bard/davol ventralex and non bard/davol mesh. It is alleged that the patient is at higher risk of severe complications during an abdominal surgery. It is alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish and emotional distress. It is also alleged that the patient have been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment. Attorney alleges "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent impairment. ".
 
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Brand NameMESH ¿ VENTRALEX
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 Key14533661
MDR Text Key293341961
Report Number1213643-2022-94185
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2018
Device Catalogue Number0010302
Device Lot NumberHUXC1466
Was Device Available for Evaluation? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2013
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: 05/28/2022 Patient Sequence Number: 1
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