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

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.

• 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 Key: 6340163
• MDR Text Key: 67717013
• Report Number: 1213643-2017-00118
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/17/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention; Disability