MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number UNKAA030

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930)

Event Date 08/29/2021

Event Type  Injury  

Manufacturer Narrative

As alleged post implant of a bard mesh the patient experienced pain, infection and mesh migration.Multiple attempts have been made to obtain additional information.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists pain, infection and migration as possible complications.In regards to infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." additionally, the ifu states, ¿ care should be taken to ensure that the mesh is adequately fixated to the abdominal wall.If necessary additional fasteners and/or sutures should be placed.¿ should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

Per maude event report (mw5103805): "still have the original hernia patch from 2005.I think it may be a bard patch put in (b)(6) 2005 by dr.(b)(6).I have not been contacted at all about the patch by the surgeon.I believe he is in (b)(6) practicing there.I think it has migrated? staples may have let go? i think is a 10-inch size.I have not trusted this thing since it was placed in.I had a low-grade fever after surgery for a couple years.Told to return to work in just 4 weeks? not long enough.I do not think.My job was very physical.I cleaned a school.A labor job really.Now 16 years later i am experiencing pain in my abdomen.I have gained weight due to depression medication.A considerable amount of weight (b)(6) pounds heavier now? menopause has passed now and i feel horrible.I am just glad i did not get pregnant after this patch was put in.I would have been too afraid to have a baby.Not sure what to do at this point.I had it checked once right after the surgery and they said they could not see it so it may have still been ok.My doctor, doctor (b)(6) has not sent me to get it checked.I did see a surgeon who said he would put one over top.I do not want that.(b)(6) also in (b)(6) where my doctor is.I think it could be infected.I am experiencing pain upon bending and working outdoors.I have pain that i do not understand in my abdomen.Kind of hurts to the touch.It could be infection.I want a surgeon that would not just put another one in but one that would look for staples too that were used to put it in there.I wanted stitches.He said my organs were stuck together but that could be from child-rape.Yeah, i was 5.Now i may be needing it out.Robotic surgery seems to be the safest sounding one but not if staples are floating around inside me? any help would be appreciated.(b)(6) hernia patch check, not positive on the date i had it checked there.Bard? 2005 placement.Fda safety report id (b)(4).Concomitant medical products: zoloft, pan medication over counter.".

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12615029
• MDR Text Key: 276688909
• Report Number: 1213643-2021-20355
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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
• Date Manufacturer Received: 09/22/2021
• 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