MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for NATRELLE SMOOTH MODERATE HIGH TISSUE EXPANDER 400CC 133 SMX-12-T manufactured by Allergan.
[185243668]
Reporter stated that she received a tissue expander after a mastectomy on (b)(6) 2019. She alleged that she was not provided any assistance after discharge and was sent home with a hematoma. Within a few days she had blue and purple swelling on her entire chest area. She went back for a f/u and was seen bu and pa and not the dr. She was told that she would need to "clean up the edges and drain blood from the site". She stated that they completely opened her up and removed 2. 5in of skin. She reported that it was as if she had 2 surgeries in 4 days. Three months later, she went to a different dr and was told that she had a seroma and it needed to be drained. She stated that her incision would not heal, she has had "a lot of complications" and has wasted a lot of money. She insisted that these tissue expanders are not made correctly to fit the human body and that the fda "should do something about it. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093901 |
| MDR Report Key | 9871707 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-11-04 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 |
| Brand Name | NATRELLE SMOOTH MODERATE HIGH TISSUE EXPANDER 400CC |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-23 |
| Model Number | 133 SMX-12-T |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |