SIZER, MAMMARY, BREAST IMPLANT VOLUME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for SIZER, MAMMARY, BREAST IMPLANT VOLUME manufactured by .

Event Text Entries

[181144872] Breast implants that were removed. Patient with bilateral capsular contracture and ruptured implants. Per pathology report: breast, right: received is a 166 g, 9. 4 x 9. 4 x 4. 4 cm previously disrupted breast implant with a smooth, clear, colorless wall. The wall displays a 1. 5 cm slit-like transmural defect, extruding thick gelatinous clear, colorless material. A definitive inscription is not grossly appreciated. Breast, left: received fresh is a 182 g, 13. 0 x 8. 0 x 3. 5 cm previously disrupted saccular portion of tan-pink membranous tissue with extruding clear, colorless gelatinous material the membranous tissue has adherent lobulated, yellow, glistening adipose tissue and is focally thickened. A definitive inscription is not grossly appreciated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9763434
MDR Report Key9763434
Date Received2020-02-27
Date of Report2020-02-21
Date of Event2020-02-12
Report Date2020-02-21
Date Reported to FDA2020-02-21
Date Reported to Mfgr2020-02-27
Date Added to Maude2020-02-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSIZER, MAMMARY, BREAST IMPLANT VOLUME
Product CodeMRD
Date Received2020-02-27
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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