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Adverse Event Report

MCGHAN CORPORATION MCGHAN BREAST IMPLANT   back to search results
Model Number 133 MV 500CC
Device Problem Implant, removal of
Event Date 12/11/2002
Patient Outcome  Other;
Event Description

This patient underwent surgery of the following: 1) delayed left breast reconstruction with a right free tram flap, 2) right breast mastopexy, 3) removal of right upper chest mediport, and 4) left breast implant removal and capsulectomy. It was suspected that the left breast tissue expander had a slow leak. Examination of the implant after removal in surgery indicated a leak just superior and to the left of the valve viewing the implant from its anterior surface.

 
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Brand NameMCGHAN
Type of DeviceBREAST IMPLANT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
MCGHAN CORPORATION
700 ward drive
santa barbara CA 93111 2936
Manufacturer (Section D)
MCGHAN CORPORATION
700 ward drive
santa barbara CA 93111 2936
Device Event Key424749
MDR Report Key435828
Event Key412443
Report Number435828
Device Sequence Number1
Product CodeFWM
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/26/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number133 MV 500CC
Device LOT NumberPF5189
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/26/2002
Distributor Facility Aware Date12/11/2002
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer12/26/2002
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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