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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010208
Device Problems Defective Device (2588); Folded (2630); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)
Event Date 01/28/2013
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event. The patient's attorney did not allege a specific device failure and medical records have not been provided. Without a lot number a review of the manufacturing records could not be conducted. With the currently available information, no conclusion can be drawn. 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: patient underwent hernia repair surgical procedures, and during the course thereof the hernia repair product was implanted. The attorney alleges the patient experienced pain and suffering, injury and was seriously and permanently injured.
 
Manufacturer Narrative
Addendum to the previous report. This supplemental emdr is being sent to provide additional information based on a medical record review. The medical records provided indicate the patient experienced adhesions, abscess, infection and fistula. The medical records do no specify which of the implanted mesh devices may have caused or contributed to the patient's symptoms. The medical records provided did not include any operative details for the two implant procedures in 2004 and 2012, therefore, the anatomical location of the meshes implanted is unknown at this time. Although there is unclear which mesh may have caused or contributed to the patient's symptoms experienced, adhesions and fistula are listed as known possible adverse reactions in the instructions-for-use. In regards to infection the warning section of the 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 current information available, no definitive conclusion can be made at this time. If additional event and/or evaluation information is obtained, this report will be updated. The subject product is part of the composix kugel recall.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2004 - the patient underwent implant of a bard composix kugel hernia mesh and a non-bard davol mesh. No operative details were provided for this procedure. On (b)(6) 2012 - the patient underwent an incision and drainage of an abdominal wall abscess. No operative details were provided for this procedure. On (b)(6) 2013 - the patient was diagnosed with abdominal wall abscess, infected prosthetic mesh of the abdominal wall. The patient underwent an incision and drainage of abdominal wall abscess with debridement of abdominal wall, removal of infected prosthetic mesh, small bowel resection with primary anastomosis, repair of abdominal wall hernia with implant of a non bard davol "vicryl" mesh. Per operative details "at the side where the abscess pocket was appreciated the mesh had folded on itself anteriorly and there appeared to be small bowel loops adherent to the mesh and there was evidence of an enterocutaneous fistula. On exploration there was bilious discoloration of the mesh material. At this point the mesh was dissected out from the abd wall removing it completely. " on (b)(6) 2013 - the patient was admitted to the hospital with septic shock. She had undergone repair of a large ventral hernia in the weeks preceding her admission. The patient was placed on broad spectrum antibiotics. A work-up found (b)(6) growing from her abdominal drainage (drains were still in place from surgery). The patient's sepsis resolved during her course. The patient worked with pt/ot and grew stronger during her stay.
 
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Brand NameMESH - COMPOSIX KUGEL
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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key5679148
MDR Text Key45904592
Report Number1213643-2016-00233
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2009
Device Catalogue Number0010208
Device Lot Number43FOD336
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0526-06

Patient Treatment Data
Date Received: 05/25/2016 Patient Sequence Number: 1
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