MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for MENTOR CPX4 450ML TISSUE EXPANDER 350-9213 manufactured by Mentor Worldwide Llc.
[144179794]
Ruptured right breast tissue expander.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086368 |
| MDR Report Key | 8577959 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-22 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | MENTOR CPX4 450ML TISSUE EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2019-05-02 |
| Model Number | 350-9213 |
| Lot Number | 7662058 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR WORLDWIDE LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |