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Adverse Event Report

DOW CORNING CORP. GEL-FILLED MMRY IMPLANT UNKNOWN MFR MAM IMP GEL-FILLED   back to search results
Event Type  Injury   Patient Outcome  Other;
Event Description

Pt alleges her breasts keep hurting under the nipples and has discharge from the nipples due to implants.

 
Manufacturer Narrative

12/07/99 - sent 1st attempt letter requesting add'l info. 12/21/99 - sent 2nd attempt letter requesting add'l info. The following dates are estimated. Only the year is known: a. 2. Date of birth. D. 7. Date implanted.

 
Search Alerts/Recalls

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Brand NameGEL-FILLED MMRY IMPLANT UNKNOWN MFR
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 CORPORATION
1635 n. gleanor road
hemlock MI 48626
Manufacturer Contact
jan classens
3901 s. saginaw road
midland , MI 48640
(517) 496 -5140
Device Event Key249057
MDR Report Key257189
Event Key241061
Report Number1816403-1999-00375
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 12/02/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NOT APPLICABLE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/1999
Was Device Evaluated By Manufacturer? No
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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