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

Catalog Number 5954450

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Neuropathy (1983); Hernia (2240); Disability (2371)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the bard/davol ventralight st device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent revision surgery of recurrent hernia.No medical records have been provided; however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr 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 alleged by the patient's attorney: on (b)(6) 2014: the patient underwent an implant with a bard/davol ventralight st mesh, reference number 5954450.No less than a year had passed before the patient started experiencing pain radiating from his abdomen and neuropathy.On (b)(6) 2016: the patient underwent repair surgery of recurrent umbilical hernia with sutures.As alleged, as a result of having the "product" implanted in him, the patient has suffered pain, neuropathy, scarring and experienced significant physical pain and suffering.It is alleged the bard/davol ventralight st mesh is defective.

• Brand Name: VENTRALIGHT ST
• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7610184
• MDR Text Key: 111348993
• Report Number: 1213643-2018-02003
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5954450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• 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