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 .
[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
| Report Number | 9763434 |
| MDR Report Key | 9763434 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-12 |
| Report Date | 2020-02-21 |
| Date Reported to FDA | 2020-02-21 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2020-02-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |