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

Catalog Number UNKAA078

Device Problems Material Deformation (2976); Migration (4003)

Patient Problems Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the ventralight st mesh may have caused or contributed to the events as alleged.The maude event report did not provide contact information for the complainant, therefore at this time we are unable to request additional information.Infection and recurrence are known inherent risks of hernia repair surgery.Regarding infection and recurrence the instructions-for-use states."if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." and "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect at least 3 to 5 cm." a lot number was not provided, without this information a review of the manufacturing records is not possible.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.Not returned.

Event Description

The following was reported via maude event report (mw5078177): "abdominal mass surgery required an emergency mesh implant of a bard ventralight st.Within a week i developed a serious infection and was hospitalized.My wound did not close within 5 months.Even with assistance from a wound vac.I started having bowel problems, cysts, fevers, infections, wound drainage, teeth deterioration, pain, inflammation, bloating, swelling, heat generating from my stomach where my mesh was.I developed a hernia, and found that my mesh had dislocated and was in a ball.I also developed streptococcus b.On (b)(6) 2018, i had my mesh removed and my hernia repaired.Since the mesh was removed, i have not had an infection, my wound closed fully within 3 weeks.The pathology reported rendered on the removed, mesh came back infected and dislocated.".

• 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7739800
• MDR Text Key: 115711670
• Report Number: 1213643-2018-02557
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• 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