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Adverse Event Report

DOW CORNING CORP. SILASTIC II MMRY G/S LPR 150/190 MAM IMP GEL-SALINE   back to search results
Model Number P0340150
Event Type  Injury   Patient Outcome  Other;
Event Description

Operative report shows patient had painful hard breast capsules and open capsulectomies were performed. Operative report also states patient's left implant was defective; therefore, she had removal and replacement of the device.

 
Manufacturer Narrative

Conclusions: no device returned, no conclusion can be drawn.

 
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Brand NameSILASTIC II MMRY G/S LPR 150/190
Type of DeviceMAM IMP GEL-SALINE
Baseline Brand NameSILASTIC II GEL SALINE MAMMARY IMPLANT, H.P., LPR
Baseline Generic NameMAMMARY IMPLANT, GEL-SALINE
Baseline Catalogue NumberP0340150
Baseline Device FamilyBREAST IMPLANT, GEL-SALINE
Baseline Device 510(K) NumberK895960
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/01/1979
Date Ceased Marketing01/01/1992
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
Manufacturer Contact
james vellender
3901 s saginaw road
midland , MI 48640
(517) 496 -5140
Device Event Key209035
MDR Report Key215492
Event Key202198
Report Number1816403-1999-00123
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/1991
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? No
Device Operator NOT APPLICABLE
Device MODEL NumberP0340150
Device Catalogue NumberP0340150
Device LOT NumberHH128654
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/1992
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/1989
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 February 28, 2009

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