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Adverse Event Report

DAVOL INC, SUB C.R. BARD, INC. DAVOL 1/4" MED/LARGE FLAT ROUND DRAIN   back to search results
Device Problems Removal difficulties; Tears, rips, holes in device, device material
Event Date 02/09/2004
Patient Outcome  Hospitalization;
Event Description

In 2004 pt underwent an anterior exenteration, bilateral pelvic lymphadenectomy, ileal conduit, bilateral ureteral ileal anastomoses. The following month, the surgeon attempted to remove a drain without success. The following day, the pt returned to the or for drain removal. Upon removal, a partial tear was noted in the drain at the level of the superficial drain holes where drain exits the pt's abdomen.

 
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Brand NameDAVOL
Type of Device1/4" MED/LARGE FLAT ROUND DRAIN
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DAVOL INC, SUB C.R. BARD, INC.
100 sockanossett crossroad
po box 8500
cranston RI 02920 5539
Manufacturer (Section D)
DAVOL INC, SUB C.R. BARD, INC.
100 sockanossett crossroad
po box 8500
cranston RI 02920 5539
Device Event Key516367
MDR Report Key527196
Event Key500449
Report Number527196
Device Sequence Number1
Product CodeGCY
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/29/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
OTHER Device ID NumberPART #7032
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/23/2004
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer03/29/2004
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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