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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX E/X SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX E/X SURGICAL MESH Back to Search Results
Catalog Number 0123113
Device Problems Defective Device; Insufficient Information
Event Date 02/09/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Medical records have not been provided. It is alleged the patient experienced fistula, pain, infection, additional surgical procedure and explant. Fistula is listed as a known possible adverse reaction in the instructions-for-use. In regards to infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ a manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. If additional event and/or evaluation information is obtained, a follow up 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. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent a ventral hernia repair with implant of a bard composix e/x mesh. On (b)(6) 2015 - it was reported the patient had the mesh removed after it allegedly became infected and her small-bowel became fistula to her mesh. It is alleged the patient experienced infection, fistula, pain and additional surgical procedure, disability and explant.

 
Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2006 - the patient was diagnosed with multiple ventral hernias with extensive adhesions. The patient underwent a laparoscopic lysis of adhesions, laparoscopic ventral hernia repair with composix e/x mesh. Operative dictation notes "multiple loops of bowel were kinked and included in adhesions to the abdominal wall. Multiple ventral hernias were noted along the midline into the right side as well. Over two hours were spent taking down adhesions. " on (b)(6) 2015 - the patient was admitted to the hospital with a diagnosis of infected mesh. The medical records provided indicated that the patient had undergone previous hernia repair with mesh x2. No medical records were provided in regards to the other mesh implanted for hernia repair, therefore mesh type, implant time frame and location of implant are unknown. The patient underwent an esophagogastroduodenoscopy and peg tube placement along with explant of the mesh, resection of the small bowel and temporary abdominal closure using non-bard davol dressing. Per the medical indications the patient had been having fevers and pain around the "mesh site" which did not get better with antibiotics. (of note, operative details for the explant procedure were not provided. ) on (b)(6) 2015 - the patient underwent reopening of recent laparotomy, abdominal washout, temporary placement of abdominal dressing and placement of malecot drain as ileostomy. On (b)(6) 2015 - the patient underwent exploratory laparotomy, abdominal hernia repair with unknown mesh, bilateral cutaneous advancement skin flaps for repair and secondary closure of abdominal wound. Of note, per operative dictation "due to her recent washout with a fistula formation, we elected to close her today with vicryl mesh and to deal with her hernia later. ".

 
Manufacturer Narrative

Addendum to the initial report. This supplemental emdr is being sent due additional information received from limited medical records provided to davol by the patient's attorney. The limited medical records indicate that this was a patient who had previously undergone hernia repair surgery with implant of mesh x2. No medical records were provided in regards to the other mesh implanted for hernia repair, therefore mesh type, implant time frame and location of implant are unknown. The medical records provided for the implant procedure of the composix e/x mesh in 2006 did not mention any visualization or manipulation of another mesh device, furthermore, the medical records provided for the explant procedure in 2015 did not provide any details as to which mesh may have been explanted during the procedure. The medical records indicate the patient experienced fistula, pain, recurrence and infection. The symptoms experienced by the patient appear to have occurred nine years post implant of the composix e/x mesh. At this time the etiology of these symptoms is unknown, as the medical course between the implant of the composix e/x mesh in 2006 and the explant of composix e/x mesh in 2015 is unknown. While we can not determine which mesh was involved in the (b)(6) 2015 procedure, in regards to fistula and hernia recurrence, they are both listed as known possible adverse reaction in the composix e/x instructions-for-use. In regards to infection, the warning section of the composix e/x instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ with the information provided, it is unclear at this time to what extent the composix e/x mesh may have caused or contributed to the issues experienced post implant. If additional event and/or evaluation information is obtained, this report will be updated.

 
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Brand NameCOMPOSIX E/X
Type of DeviceSURGICAL 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
steven figueroa
100 crossings blvd.
warwick , RI 02886
4018258460
MDR Report Key6329085
Report Number1213643-2017-00108
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2011
Device Catalogue Number0123113
Device LOT Number43AQD327
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/14/2017 Patient Sequence Number: 1
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