MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-14 for SUPERTRAX AK100101-01 21 * manufactured by Superdimenson, Ltd..
Report Number | 3033441 |
MDR Report Key | 3033441 |
Date Received | 2013-02-14 |
Date of Report | 2013-02-14 |
Date of Event | 2013-01-08 |
Report Date | 2013-02-14 |
Date Reported to FDA | 2013-02-14 |
Date Reported to Mfgr | 2013-04-03 |
Date Added to Maude | 2013-04-03 |
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 | 3 |
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 | SUPERTRAX |
Generic Name | BIOPSY |
Product Code | GAA |
Date Received | 2013-02-14 |
Model Number | AK100101-01 21 |
Catalog Number | * |
Lot Number | SD06-12-215 |
ID Number | * |
Operator | PHYSICIAN |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SUPERDIMENSON, LTD. |
Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 MINNEAPOLIS MN 55441543 US 55441 5433 |
Brand Name | SUPERTRAX |
Generic Name | BIOPSY |
Product Code | DWO |
Date Received | 2013-02-14 |
Model Number | AK100101-01 21 |
Catalog Number | * |
Lot Number | 15356 |
ID Number | * |
Device Availability | N |
Device Age | * |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | SUPERDIMENSON, LTD. |
Manufacturer Address | 161 CHESHIRE LANE, SUITE 100 MINNEAPOLIS MN 55441543 US 55441 5433 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-02-14 |