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Adverse Event Report

ETHICON, INC. BLAKE DRAIN WOUND DRAINAGE SYSTEM   back to search results
Catalog Number 2232
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/28/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Affiliate reported that the device was placed following proctectomy and removed five days later. An intestinal perforation was found at reoperation 13 days following placement of the device. Necrotic tissue was excised and intestine repaired. Pt is recovering.

 
Manufacturer Narrative

This is one of two medwatch reports being submitted as two separate devices were used. See 2210968-2004-00463 for the other medwatch. The same pt is represented in each medwatch. H-6 no conclusion can be drawn at this time.

 
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Brand NameBLAKE DRAIN
Type of DeviceWOUND DRAINAGE SYSTEM
Baseline Brand NameBLAKE DRAINS
Baseline Generic NameWOUND DRAINAGE SYSTEM
Baseline Catalogue NumberNA
Baseline Model Number2232
Baseline Device FamilyWOUND DRAINAGE PRODUCTS
Baseline Device 510(K) NumberK953655
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed08/01/1982
Manufacturer (Section F)
ETHICON, INC.
route 22 west
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON, INC.
route 22 west
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section G)
INNOVATIVE SURGICAL PRODUCTS
1201 east wakeham
santa ana CA 92705
Manufacturer Contact
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key532394
MDR Report Key543022
Event Key515694
Report Number2210968-2004-00464
Device Sequence Number1
Product CodeGCY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/13/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date03/31/2009
Device Catalogue Number2232
Device LOT Number40481
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/28/2004
Device Age4 mo
Event Location Hospital
Date Manufacturer Received08/13/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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