MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-07-02 for manufactured by .
| Report Number | 1423537-1997-00104 |
| MDR Report Key | 103067 |
| Report Source | 05,06 |
| Date Received | 1997-07-02 |
| Date of Event | 1997-05-05 |
| Date Mfgr Received | 1997-06-20 |
| Date Added to Maude | 1997-07-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KBE |
| Date Received | 1997-07-02 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 100228 |
| Baseline Brand Name | KRAUSE WIRE CARRIER |
| Baseline Generic Name | WIRE CARRIER |
| Baseline Model No | RH652-170 |
| Baseline Catalog No | RH652-170 |
| Baseline ID | NA |
| Baseline Device Family | WIRE CARRIER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-02 |