MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-24 for SMOOTH SALINE BREAST IMPLANTS manufactured by Mentor.
[78602922]
This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldn't recover from anything, feeling like i was literally going to die. Extreme endocrine (blood sugar fluctuations). Inability to sweat. Heat and cold intolerance. Rashes and sensitivities to any lotions, perfumes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070655 |
| MDR Report Key | 6669668 |
| Date Received | 2017-06-24 |
| Date of Report | 2017-06-24 |
| Date of Event | 1997-11-24 |
| Date Added to Maude | 2017-06-27 |
| 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 SALINE BREAST IMPLANTS |
| Generic Name | SMOOTH SALINE BREAST IMPLANTS |
| Product Code | FWM |
| Date Received | 2017-06-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Brand Name | SMOOTH SALINE BREAST IMPLANTS |
| Generic Name | SMOOTH SALINE BREAST IMPLANTS |
| Product Code | FMW |
| Date Received | 2017-06-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2017-06-24 |