MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number 0115311

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided an unresorbed suture was assessed by the doctor to be the primary source of the patient's infection.At this time no definitive conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Regarding infection the warning section states, if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.A unresolved infection, however, may require removal of the prosthesis.If additional information is obtained, a supplemental 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.Remains implanted.

Event Description

The following was reported to davol.In (b)(6) 2009 the patient underwent the repair of bilateral inguinal hernias and was implanted with a right 3dmax mesh and a left 3dmax mesh.As reported in (b)(6) 2014 the patient presented to the er with complaints of swelling and redness in the left groin area.The patient was diagnosed with an infection and treated with oral antibiotics with good results.In (b)(6) 2016 it is reported that the patient again experienced redness and swelling in the left groin area and was seen at a surgeons office.The surgeon noted a suture that should have absorbed was involved and removed.The patient was prescribed oral antibiotics and culture reports indicated e.Coli in the wound.Per contact the surgeon indicated that the suture seemed to be the primary source of the patient's infection.The patient completed the course of antibiotics with some improvement.At this time the patient is experiencing a hardened area and redness in the left groin area.

• Brand Name: 3DMAX
• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6199678
• MDR Text Key: 63183590
• Report Number: 1213643-2016-00586
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 0115311
• Device Lot Number: HUTH1334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2009
• 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