MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-20 for AVAULTA BIOSYNTHETIC SUPPORT SYSTEM 486010 manufactured by Sofradim Production.
[15155347]
It was alleged by the patient's attorney: "following an anterior repair and a posterior repair performed in 2007, the patient experienced mental and physical pain and suffering, permanent injury, physical deformity, loss of a bodily organ system and has undergone or will undergo corrective surgery or surgeries". An inquiry was forwarded to the patient's physician who responded that all inquiries concerning this patient should be forwarded to his attorney. The patient's attorney provided the patient's implant card. The diagnosis and type of treatment for this specific patient is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2009-00062 |
| MDR Report Key | 3618946 |
| Date Received | 2009-06-20 |
| Date of Report | 2009-06-11 |
| Date Facility Aware | 2009-05-13 |
| Report Date | 2009-06-11 |
| Date Reported to FDA | 2009-06-11 |
| Date Reported to Mfgr | 2009-06-11 |
| Date Added to Maude | 2014-02-11 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer G1 | C.R. BARD, INC. |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| 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 | 2009-06-20 |
| Model Number | NA |
| Catalog Number | 486010 |
| Lot Number | ZGJ00188 |
| ID Number | NA |
| Device Expiration Date | 2011-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| 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 | 2009-06-20 |