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Adverse Event Report

DOW CORNING CORP. SILASTIC MMRY LPC FP MAM IMP GEL FILLED   back to search results
Lot Number HH05998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pathology report states ruptured left breast implant. Report also alleges left breast mass with four irregular pieces of fibroadipose breast tissue.

 
Manufacturer Narrative

D6 - lot number provided (hh05998) is incorrect or incomplete; however, the device returned is a dow corning unit. The catalog number provided (594) does not correspond with the device that was returned; therefore, co is unable to determine the correct lot and catalog numbers for this device. Method: weight measurement. Results: slight amber color, foreign material. Loss of shell integrity, envelope tear. Conclusions: foreign material cause and source undetermined, tear(s) caused by stress.

 
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Brand NameSILASTIC MMRY LPC FP
Type of DeviceMAM IMP GEL FILLED
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DOW CORNING CORP.
1635 n. gleaner rd.
hemlock MI 48626
Manufacturer (Section D)
DOW CORNING CORP.
1635 n. gleaner rd.
hemlock MI 48626
Manufacturer (Section G)
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
1635 n. gleaner rd.
p.o. box 20
hemlock MI 48626
Device Event Key209143
MDR Report Key215602
Event Key202306
Report Number1816403-1999-00115
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/08/1990
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NOT APPLICABLE
Device LOT NumberHH05998
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/1990
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/1990
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
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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