MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-13 for manufactured by .
| Report Number | 9610617-2000-00022 |
| MDR Report Key | 300044 |
| Report Source | 05,06 |
| Date Received | 2000-10-13 |
| Date of Event | 2000-09-21 |
| Device Manufacturer Date | 1985-01-01 |
| Date Added to Maude | 2000-10-17 |
| 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 |
| Manufacturer Street | MITTELSTRASSE 8 POSTFOCH 230 |
| Manufacturer City | TUTTLINGEN 20850 |
| Manufacturer Country | GM |
| Manufacturer Postal | 20850 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KCD |
| Date Received | 2000-10-13 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 290426 |
| Baseline Brand Name | KARL STORZ |
| Baseline Generic Name | KARL STORZ ESOPHAGEAL DILATOR |
| Baseline Model No | 10392A |
| Baseline Catalog No | 10392A |
| Baseline ID | LO |
| Baseline Device Family | DILATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K946331 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-13 |