MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-09 for A-V GRAFT manufactured by Impra, Inc..
[10985]
Possible allergic reaction to a-v graft. Pt returned to surgery for removal of a-v graft. This reaction is possibly unique to this particular pt and not a universal problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 14997 |
| MDR Report Key | 14997 |
| Date Received | 1994-06-06 |
| Date of Report | 1994-06-03 |
| Date of Event | 1994-05-26 |
| Date Facility Aware | 1994-05-26 |
| Report Date | 1994-06-03 |
| Date Reported to FDA | 1994-06-03 |
| Date Reported to Mfgr | 1994-06-03 |
| Date Added to Maude | 1994-08-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A-V GRAFT |
| Generic Name | A-V GRAFT |
| Product Code | FIQ |
| Date Received | 1994-06-09 |
| Returned To Mfg | 1994-06-03 |
| Lot Number | 30193-1 |
| ID Number | CFT454-7 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 14991 |
| Manufacturer | IMPRA, INC. |
| Manufacturer Address | TEMPE AZ 852801740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-06-06 |