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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954680
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Fluid Discharge (2686)
Event Date 06/02/2020
Event Type  Injury  
Event Description
Attorney alleges that the patient was implanted with bard/davol ventralight st mesh and non-bard/davol mesh, collectively known as "mesh products". Attorney alleges that on or about (b)(6) 2013, the patient was implanted with a non-bard/davol mesh to repair an umbilical hernia. "as a direct and proximate result of defendants¿ defective design, manufacture, marketing, distribution, and/or sale of non-bard/davol mesh and the ventralight st mesh and placing the defective products into the stream of commerce, the patient has been injured and damaged as follows¿: it is alleged that on or about (b)(6) 2019, the patient underwent revision of the non-bard/davol mesh. It is alleged that on or about (b)(6) 2020, the patient underwent revision of the non-bard/davol mesh and underwent midline hernia repair. A bard/davol ventralight st mesh was implanted in the patient during this repair. It is alleged that on or about (b)(6) 2021, the patient underwent revision of the mesh products and underwent midline hernia repair. A bard/davol ventralight st mesh was implanted in the patient during this repair. It is alleged that on or about (b)(6) 2020, the patient underwent revision of the mesh products. It is alleged that on or about (b)(6) 2021, the patient underwent revision of the mesh products. It is also alleged that on or about (b)(6) 2021, the patient underwent revision of the mesh products. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, dense adhesions, adhesions to bowel, dense scarring, infection, open draining wound, recurrence, and abdominal wall reconstruction, which have impaired the activities of daily living. It is alleged that the patient continues to suffer complications as a result of implantation with the mesh products. It is alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible. It is alleged that at the time the ventralight st was implanted in the patient's body, the product was defectively manufactured. It is alleged that "the (ventralight) st mesh implanted in the patient failed to reasonably perform as intended. The (ventralight) st mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the (ventralight) st bard mesh was initially implanted to treat". 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. Attorney also 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.
 
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, infection, pain, hernia recurrence, adhesions and inflammation. The instructions-for-use supplied with the device lists hernia recurrence, infection, adhesions and inflammation as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " this emdr represents the bard/davol ventralight st mesh (device #1). An additional emdr was submitted to represent the bard/davol ventralight st mesh (device #2). Should additional information be provided, a supplemental emdr will be submitted. The information provided by bd 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 bd. Not returned.
 
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Brand NameVENTRALIGHT ST 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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key14742702
MDR Text Key294878624
Report Number1213643-2022-94799
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
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 06/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number5954680
Device Lot NumberHUDN1240
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2019
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: 06/20/2022 Patient Sequence Number: 1
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