MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for PELVIC MESH manufactured by Unk.
[182387157]
Add'l surgeries; i was implanted with pelvic mesh for a cystocele and rectocele repair as well as a bladder sling. I've had multiple revision surgeries because of pain and other symptoms from mesh extrusion. I'm a masters educated nurse and have lost my job, my health, and my future. I am totally disabled and unable to work since 2011. I went from incredibly healthy to disabled within 6 years with my health rapidly decreasing from implant onwards. I am now facing a life-threatening and expensive surgery to attempt to remove all of the mesh. It has been an absolute nightmare. I'm only (b)(6) and i've lost the last 10-15 years of my life to this mesh. I have autoimmune diseases that i believe were brought on by the chronic inflammation and infection of my mesh. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093510 |
| MDR Report Key | 9786049 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-29 |
| Date of Event | 2005-09-18 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Brand Name | PELVIC MESH |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN |
| Product Code | PAI |
| Date Received | 2020-03-03 |
| Device Availability | Y |
| 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. Hospitalization; 2. Other; 3. Deathisabilit | 2020-03-03 |