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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX SURGICAL MESH Back to Search Results
Catalog Number 0113360
Device Problems Degraded (1153); Material Too Rigid or Stiff (1544)
Patient Problems Bacterial Infection (1735); Fistula (1862); Sepsis (2067)
Event Date 06/02/2014
Event Type  Injury  
Manufacturer Narrative
Based on the information provided and the patient's complex medical history, at this time no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Fistula formation, adhesions, and inflammation are all listed in the adverse reaction section of the ifu as possible complications. Regarding infection the warning section 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. If additional information is obtained, a supplemental 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.
 
Event Description
The following is based on medical records provided by the patient's attorney: on (b)(6) 2004- the patient was implanted with a bard / davol composix mesh for the repair of a ventral incisional hernia that developed at an old site of an ileostomy duct. On (b)(6) 2014 - the patient developed an enterocutaneous fistula and underwent a laparotomy, lysis of adhesions, small bowel resection, excision of the bard mesh and repair of the ventral hernia with a non bard/davol biologic graft. The fistula was identified in the right lower quadrant and noted to be intermittently associated with the previous mesh hernia repair. The fistula tract and mesh were excised. The bowel contamination was controlled at the site of the fistula and a small bowel resection and an end to end anastomosis were performed. Postoperatively the patient was diagnosed with tachycardia, he was intubated and due to signs of septic shock was moved to the icu. On (b)(6) 2014 - the patient was diagnosed with septic shock secondary to intra-abdominal sepsis and significant intraperitoneal contamination due to an enterotomy. He underwent a laparotomy, lysis of adhesions, resection of the enterotomy site and abdominal wash out with temporary wound closure. On (b)(6) 2014 - the patient underwent a laparotomy, drainage of an abdominal abscess and temporary wound closure. On (b)(6) 2014 - the patient required prolonged mechanical ventilation and underwent a tracheostomy procedure. During preparation it was noted that the patient's abdominal wound incision had stool leaking from it. After the tracheostomy was performed the surgeon performed an emergent laparotomy and noted a small hole in the small bowel at the level of the previous hand-sewn anastomosis, intra-abdominal collections were drained, and a temporary malecot drain was placed. On (b)(6) 2014 - an abdominal ct scan showed the patient had developed a fistula from the abdominal wall down to the peritoneal surface just lateral to the open ventral incision. On (b)(6) 2014 - the patient was transferred to a skilled nursing rehabilitation facility. There was no additional information provided.
 
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Brand NameMESH - COMPOSIX
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5871267
MDR Text Key51931658
Report Number1213643-2016-00379
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K971745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2008
Device Catalogue Number0113360
Device Lot Number43GND132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2003
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: 08/12/2016 Patient Sequence Number: 1
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