MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for MENTOR COHESIVE GEL SILICONE BREAST IMPLANT 6736575-003 18006368678 manufactured by Mentor.
[124311390]
Implant ruptured totally liquid in my chest cavity. Other side had grade 4 capsular contracture. Had only been in 6 yrs. I've now had 3 surgeries. Now getting a liver biopsy for an unspecified tumor. Cannot work 40+ symptoms including heart failure/tachycardia. Liver tumor, h. Pylori, tachycardia, heart palpitation, chronic fatigue, brain fog, dizziness, fainting, tremors, depression, and ptsd, suicidal thoughts, acid reflux, heartburn, migraines chest pain, vomiting black stool, kidney failure, vision problems, electric shocks throughout my brain, high blood pressure, dyspnea, bloating, upper right abdominal pain, breast pain, breast numbness, breast tingling, armpit pain, back pain, shoulder pain, leg tremors, edema, blood clots, joint pain, chronic inflammation, elevated white blood cells, high sedimentary rate, elevated liver enzymes, insomnia, anxiety, pain, fluid retention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080605 |
| MDR Report Key | 7973536 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-10-17 |
| 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 | MENTOR COHESIVE GEL SILICONE BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE |
| Product Code | FTR |
| Date Received | 2018-10-16 |
| Model Number | 6736575-003 |
| Catalog Number | 18006368678 |
| Lot Number | 259980 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR |
| Brand Name | MENTOR COHESIVE GEL SILICONE BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE |
| Product Code | FTT |
| Date Received | 2018-10-16 |
| Model Number | 6736575-003 |
| Catalog Number | 18006368678 |
| Lot Number | 259980 |
| Device Availability | * |
| 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. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2018-10-16 |