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

Catalog Number UNKAA030

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Internal Organ Perforation (1987); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The information provided is limited.Additional information has been requested.Based on the limited information provided to date, no conclusion can be made.Should additional information be obtained, a supplemental emdr will be submitted.The emdr represents bard/davol mesh #3, additional emdr have been submitted to represent bard/davol mesh #'s 1 and 2 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 to davol: the patient underwent implant of an unknown bard/davol mesh (#1).As reported, the bard/davol mesh "moved." the patient underwent additional surgery in which a second bard/davol mesh (#2) was implanted.As reported, the second bard/davol mesh "moved." the patient underwent an additional surgery in which a third bard/davol mesh (#3) was implanted.The contact reports the third mesh has moved into the patient's bladder and states the surgeon refuses to remove the mesh as surgery would be too much of a risk.

• Brand Name: BARD FLAT 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: 7287306
• MDR Text Key: 100648079
• Report Number: 1213643-2018-00340
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• 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): Life Threatening; Required Intervention