MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-08-20 for USA ELITE SYSTEM OBTURATOR E161 manufactured by Circon Acmi.
[111401]
Portion of obturator separated from sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-1998-00063 |
| MDR Report Key | 183974 |
| Report Source | 07 |
| Date Received | 1998-08-20 |
| Date of Report | 1998-08-20 |
| Date Mfgr Received | 1998-08-06 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 1998-08-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE SYSTEM OBTURATOR |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-08-20 |
| Returned To Mfg | 1998-08-06 |
| Model Number | E161 |
| Catalog Number | E161 |
| Lot Number | EW (5/93) |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 178861 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | USA ELITE SYSTEM OBTURATOR |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | E161 |
| Baseline Catalog No | E161 |
| Baseline ID | NA |
| Baseline Device Family | OBTURATOR |
| 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 | 1998-08-20 |