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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 UNKAA078
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 04/20/2015
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st mesh (device #2).An additional emdr was submitted to represent the bard/davol ventralight st mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol two ventralight st on (b)(6) 2014 and (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient sustained injuries on (b)(6) 2014 and (b)(6) 2015.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 patient experienced emotional distress and the device was defective.
 
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Brand Name
VENTRALIGHT ST MESH
Type of Device
SURGICAL 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 Key11286619
MDR Text Key230511900
Report Number1213643-2021-00831
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 consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA078
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Disability;
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