MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-04-25 for MIC1337 manufactured by Sterilmed, Inc..
[5736970]
This is a production verification test. This is not a actual complaint. This is not a actual report submission, it is only a system test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00018 |
| MDR Report Key | 4729212 |
| Report Source | * |
| Date Received | 2015-04-25 |
| Date of Report | 2015-04-25 |
| Date of Event | 2015-03-01 |
| Device Manufacturer Date | 2015-02-19 |
| Date Added to Maude | 2015-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 11400 73RD AVE N |
| Manufacturer City | MAPLE GRV MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
| Product Code | NON |
| Date Received | 2015-04-25 |
| Catalog Number | MIC1337 |
| Lot Number | 1842880 |
| Device Expiration Date | 2016-02-29 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GRV MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-25 |