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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO Back to Search Results
Catalog Number 5955460
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Fistula (1862); No Code Available (3191)
Event Date 01/01/2014
Event Type  Injury  
Event Description
The following was reported to davol: the patient was implanted with a ventralight st w/echo and a non bard/davol fixation device.During the case the doctor did not follow the prescribed method of removal and as a result a fragment of the davol inflation tube was left behind the mesh.Approximately, 3 weeks post op the patient required a procedure to repair an intestinal fistula.During the course of the procedure the previously placed mesh, and portion of the inflation assembly were explanted.As reported the root cause of the fistula formation is undetermined by the hospital/doctor.However, as reported they could not rule out the mesh or the non bard/davol fixation device as possibly contributing to the event.
 
Manufacturer Narrative
Based on the information available at this time, no definitive conclusions can be made.Fistula formation is listed in the ifu as a known possible complication.A review of the manufacturing records showed that this lot was manufactured with no anomalies.The malfunction related to the portion of the inflation device being left in the body was reported to fda as 1213643-2014-00403.As reported, there is no relationship between the portion of the inflation device being left in the body and the patients fistula formation.This mdr includes all patient, event and device information davol has received to date.If additional information is obtained, a follow up mdr will be submitted.
 
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Brand Name
VENTRALIGHT ST W/ECHO
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
cranston RI
Manufacturer (Section G)
BARD SHANNON LIMITED
lot #1, road #3, km 79.7
san geronimo industrial park
humacao PR 00791
Manufacturer Contact
laura berg
100 crossing blvd
warwick, RI 02886
8005666756
MDR Report Key4278988
MDR Text Key5034546
Report Number1213643-2014-00411
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2016
Device Catalogue Number5955460
Device Lot NumberHUYD1243
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/05/2014
Initial Date FDA Received11/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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