MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for NATRELLE 133S TISSUE EXPANDERS 600 CC WITH SUTURE TABS 133S-MX-14-T manufactured by Allergan, Inc..
[185521256]
Pt. Undergoing breast reconstruction post mastectomy. While placing natrelle allergan tissue expander into right breast area, surgeon and cst noted an area of the device appeared to be not consistent with the rest of the implant. The item was discarded and a new device was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896870 |
| MDR Report Key | 9896870 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-18 |
| Report Date | 2020-03-20 |
| Date Reported to FDA | 2020-03-20 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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 133S TISSUE EXPANDERS 600 CC WITH SUTURE TABS |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-30 |
| Model Number | 133S-MX-14-T |
| Catalog Number | 133S-MX-14-T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN, INC. |
| Manufacturer Address | 301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US 78753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |