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

Catalog Number UNKAA001

Device Problem Folded (2630)

Patient Problems Nerve Damage (1979); Pain (1994); Disability (2371)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported postoperative complication and any problem / defect with the davol device alleged to have been used to treat the patient.As reported eleven years post implant a ct scan found that the mesh had folded and the patient underwent a revision procedure.Additional information has been requested, however at this time the information provided is limited to the maude event report.Based on the information provided to date, no conclusion can be made.Without a lot number 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 (mw5074955): "i have really bad pains in the left inguinal region where i had prior surgery for an inguinal hernia.Seen surgeon who ordered cat scan.Found out that hernia mesh was folded.Had surgery to remove it but a piece was left on the inguinal ligament.I have ilioinguinal and iliohypogastric neuroglia.I have been prescribed a walking cane to help me walk.I am in pain 24/7 and the pain is worse in the evening hours.I am still going through the diagnosis stages, so i may discover more damage.".

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7359187
• MDR Text Key: 103133089
• Report Number: 1213643-2018-00707
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K953577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• 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