MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-03-30 for manufactured by .
| Report Number | 2183446-1999-00001 |
| MDR Report Key | 218669 |
| Report Source | 05,06 |
| Date Received | 1999-03-30 |
| Date of Event | 1999-03-03 |
| Date Mfgr Received | 1999-03-12 |
| Device Manufacturer Date | 1993-06-01 |
| Date Added to Maude | 1999-04-15 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FAT |
| Date Received | 1999-03-30 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 212073 |
| Baseline Brand Name | MEDOVATION ESOPHAGEAL DILATOR |
| Baseline Generic Name | MAHONEY DILATOR #58 |
| Baseline Model No | 121058 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-03-30 |