MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for NATRELLE BREAST IMPLANTS SRX-400 manufactured by Allergan Inc..
[111443454]
I had allergan natrelle inspira implants inserted on (b)(6) 2017. On (b)(6) 2018, my plastic surgeon confirmed that my breast implants have bottomed out. I got my implants less than eight months ago. I called allergan and was told that my warranty does not cover bottoming out of breast implants.
Patient Sequence No: 1, Text Type: D, B5
[137504816]
This submission is a follow-up to access number mw5077898. Friday, (b)(6): breast augmentation revision with dr. (b)(6) in (b)(6). Switched from allergan natrelle inspira 400 ml silicone gel implant, style srx-400, to sientra 300 ml smooth round ge. Total fees paid to dr. (b)(6), surgical center fees: (b)(6), anesthesia fees: (b)(6). Total fees: (b)(6). Following my surgery on (b)(6), dr. (b)(6) informed me that my left breast implant had completely ruptured. Background: dr. (b)(6) performed submuscular breast augmentation on me at (b)(6) hospital on (b)(6) 2017. He inserted natrelle inspira style srx 400 smooth round xtra-full projection silicone breast implants. Total cost: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077898 |
| MDR Report Key | 7609535 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-06-12 |
| Date Added to Maude | 2018-06-18 |
| 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 | 0 |
| Brand Name | NATRELLE BREAST IMPLANTS |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | FTR |
| Date Received | 2018-06-15 |
| Model Number | SRX-400 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN INC. |
| Brand Name | ALLERGAN NATRELLE INSPIRA 400ML SILICONE BREAST GEL IMPLANTS |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-06-15 |
| Model Number | SRX-400 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN INC. |
| Brand Name | NATRELLE BREAST IMPLANTS |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-06-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-15 |