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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX; SURGICAL MESH Back to Search Results
Catalog Number UNKAA077
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Incontinence (1928); Swelling (2091); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event.The patient's attorney did not allege a specific device failure or patient injury and medical records have not been provided.Without a lot number a review of the manufacturing records could not be conducted.With the currently available information, no conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2013 - the patient underwent hernia repair surgery with implant of a ventralex hernia mesh patch.Following the implant the patient continued to have significant pain and discomfort in her abdominal area, and other complication which included but are not limited to swelling and dropping on the right side and frequent bowel effects including increased urges which have caused uncontrollable accidents, all of which required continued treatment.Patient will likely require significant treatment in the future, including additional surgery to remove the mesh patch and treat future complications.The attorney alleges the patient experienced abdominal pain, swelling, additional medical/surgical treatment, defective mesh and disability.
 
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Brand Name
VENTRALEX
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6340163
MDR Text Key67717013
Report Number1213643-2017-00118
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 consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/23/2017
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) Required Intervention; Disability;
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