MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT 350 1670 manufactured by Mentor.
[135991679]
I? Ve had implants for 13 years. Roughly 4 years ago i started feeling a decline in my health following my third pregnancy. I attributed it all to being (b)(6) years old and hormones out of whack. My hair was falling out in clumps. It hasn? T grown back in. I? M extremely tired every day. I have dry eyes, dark circles, and red capillaries all the time. My memory is horrendous. It? S called brain fog. I can? T even remember movie plots anymore. I? Ve also put on weight which i? Ve blamed on pregnancies and age. There? S just no energy for exercise. It? S a battle. My immune system seems weaker than my family members. I get sick more frequently and hold onto them longer. Sinus infections and colds. My thyroid was tested by my doctor and found to be normal. Because my tests were normal, i truly believed i was getting old, tired, and forgetful. This has been going on for 4 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083759 |
| MDR Report Key | 8311495 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-03 |
| Date of Event | 2015-01-01 |
| Date Added to Maude | 2019-02-06 |
| 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 | SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | KWM |
| Date Received | 2019-02-05 |
| Model Number | 350 |
| Catalog Number | 1670 |
| Lot Number | 5632856 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Brand Name | SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | KWM |
| Date Received | 2019-02-05 |
| Model Number | 350 |
| Catalog Number | 1670 |
| Lot Number | 5632856 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-02-05 |