MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for VITEK PROPLAST manufactured by Unk.
[127141237]
The pt had the vitek proplast implant and was at (b)(6) in (b)(6) 2018 (5' 6 1/2"). She was unable to find anymore to help her treat her pain. Her blood pressure was at 248/123 due to pain. She had 38 facial and jaw surgeries to try to fix the proplast damage. She also had 32 others to fix her crumbling body from the teflon fragments. She had horrendous pain throughout her face, jaw and body; 13 of the proplast implants broke / ruptured inside her. Her pain dr abandoned her as he said she was too complicated. He cut her off all pain and muscle relaxers. She was unable to eat as she developed strictures in her esophagus. Water would not go down either. She would have her throat dilated every few months. Her hands were not able to be used as she developed severe arthritis everywhere. Proplast ruined her life. She had the first surgery at the age of (b)(6) and she died (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081187 |
| MDR Report Key | 8068997 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-06 |
| Date of Event | 1982-01-01 |
| Date Added to Maude | 2018-11-14 |
| 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 | UNKNOWN |
| 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 | VITEK PROPLAST |
| Generic Name | IMPLANT, MALAR |
| Product Code | LZK |
| Date Received | 2018-11-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-13 |