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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 5954460
Device Problems Migration or Expulsion of Device (1395); Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 03/01/2012
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, recurrence, adhesions, inflammation and surgical intervention. The instructions-for-use supplied with the device lists recurrence, adhesions, 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 the patient underwent a ventral hernia repair on or about (b)(6) 2011 and a bard/davol ventralight st mesh was implanted. On or about (b)(6) 2012, the patient underwent revision of the ventralight st mesh and a non-bard/davol mesh was implanted to repair a recurrent ventral hernia. On or about (b)(6) 2014, the patient underwent removal of the mesh products. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, pain and suffering, nausea, chills, inflammation, dense adhesions, mesh migration, recurrence, and surgery to remove mesh. Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is also alleged that the device was defective.

 
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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 Key11378587
MDR Text Key233494714
Report Number1213643-2021-01212
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2012
Device Catalogue Number5954460
Device LOT NumberHUUL0806
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/20/2010
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: 02/25/2021 Patient Sequence Number: 1
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