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

Catalog Number UNKAA086

Device Problems Defective Device (2588); Extrusion (2934)

Patient Problems Unspecified Infection (1930); Injury (2348); Disability (2371)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol ventralex st device used to treat the patient.The patient's attorney alleges the patient underwent an additional surgery as a result of "extruding and infected mesh"; however, no medical records have been provided.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.Note: 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.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery for implant of an unspecified bard/davol ventralex st.On (b)(6) 2017: the patient underwent surgery as a result of extruding and infected hernia mesh.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex st.As reported, the attorney alleges general allegations regarding the bard/davol ventralex 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.¿.

• Brand Name: VENTRALEX 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: 7491686
• MDR Text Key: 107512899
• Report Number: 1213643-2018-01339
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• 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: 05/07/2018

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: UNKAA086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/07/2018
• 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