MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-11-12 for AVAULTA BIOSYNTHETIC SUPPORT SYSTEM 486020 manufactured by Sofradim Production.
[4089966]
It was reported by the patient's attorney that following a posterior mesh procedure the patient has suffered from erosion, shrinkage and extrusion of mesh, urinary retention, severe pain and surgical procedures to remove the mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2009-00128 |
| MDR Report Key | 3610024 |
| Report Source | 99 |
| Date Received | 2009-11-12 |
| Date of Report | 2009-11-13 |
| Date Facility Aware | 2009-10-14 |
| Report Date | 2009-11-13 |
| Date Reported to FDA | 2009-11-13 |
| Date Reported to Mfgr | 2009-11-13 |
| Date Added to Maude | 2014-02-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVAULTA BIOSYNTHETIC SUPPORT SYSTEM |
| Product Code | FIL |
| Date Received | 2009-11-12 |
| Model Number | NA |
| Catalog Number | 486020 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION |
| Manufacturer Address | TREVOUX 01600 FR 01600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-12 |