MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for MATRISTEM manufactured by Acell.
[80306465]
Mesh erosion/exposure after davinci assisted laparoscopic sacrocolpopexy using acell (pig mesh) in (b)(6) 2013; remains unresolved despite conservative treatment and multiple office excisions of exposed mesh; unable to have intercourse for over a year now; continue to have prolapse despite mesh (i. E. Failure to treat the problem).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071015 |
| MDR Report Key | 6717756 |
| Date Received | 2017-07-13 |
| Date of Report | 2017-07-13 |
| Date of Event | 2014-07-01 |
| Date Added to Maude | 2017-07-17 |
| 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 | MATRISTEM |
| Generic Name | MESH, SURGICAL |
| Product Code | KGN |
| Date Received | 2017-07-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACELL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-07-13 |