MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2002-01-16 for USA ELITE CFR TMBLK OBT, 25F ETO-CFR-25 manufactured by Circon Acmi.
[211724]
Allegedly plastic button fell off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2002-00004 |
| MDR Report Key | 374041 |
| Report Source | 06,07 |
| Date Received | 2002-01-16 |
| Date of Report | 2002-01-16 |
| Date of Event | 2001-12-18 |
| Date Facility Aware | 2001-12-19 |
| Report Date | 2002-01-16 |
| Date Mfgr Received | 2001-12-19 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2002-01-29 |
| 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 | 3 |
| Manufacturer Contact | JOHN DELUCIA |
| Manufacturer Street | 492 OLD CONNECTICUT PATH |
| Manufacturer City | FRAMINGHAM MA 017014584 |
| Manufacturer Country | US |
| Manufacturer Postal | 017014584 |
| Manufacturer Phone | 5088790640 |
| 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 |
| Brand Name | USA ELITE CFR TMBLK OBT, 25F |
| Generic Name | 500 |
| Product Code | FEC |
| Date Received | 2002-01-16 |
| Returned To Mfg | 2001-12-19 |
| Model Number | ETO-CFR-25 |
| Catalog Number | ETO-CFR-25 |
| Lot Number | KE (11/01) |
| 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 | 363151 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | USA ELITE CFR TMBLK OBT, 25F |
| Baseline Generic Name | TIMBERLAKE OBTURATOR |
| Baseline Model No | ETO-CFR-25 |
| Baseline Catalog No | ETO-CFR-25 |
| Baseline ID | NA |
| Baseline Device Family | U1130 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-01-16 |