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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO SURGICAL MESH Back to Search Results
Catalog Number UNKAA087
Device Problem Use of Device Problem (1670)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 07/15/2016
Event Type  malfunction  
Manufacturer Narrative
Multiple attempts have been made to contact the user for additional information. As reported it appears that the prescribed removal steps may not have been followed and the inflation tube not cut correctly to facilitate removal. The method is described in the products instruction-for-use (ifu) provided with the device. The ifu it states: "to deflate the echo ps ¿ positioning system, release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube. ¿ the balloon assembly is then pulled free of the mesh and removed with the trocars. Details are limited and no conclusion can be made at this time. 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 was reported to davol: the surgeon called to report difficulty during use of the ventralight st w/ echo. The surgeon indicated that the inflation tube was not cut and that the inflation assembly was not removed in full. She was advised that the inflation assembly is not intended to be left in vivo. Multiple attempts have been made to get additional information. As reported this event may have resulted in the need for intervention, or a possible fragment being left in the body. Details are limited at this time.
 
Manufacturer Narrative
This follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files. Corrected field: (b)(4).
 
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Brand NameVENTRALIGHT ST W/ECHO
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 Key5864442
MDR Text Key51926913
Report Number1213643-2016-00376
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKAA087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/31/2017
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

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