MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-02-19 for CIRCON ACMI TIMBERLAKE OBTURATOR ETO-CFR27 manufactured by Circon Acmi.
[164051]
Pin protruding from obturator. No pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-1999-00016 |
| MDR Report Key | 211549 |
| Report Source | 07 |
| Date Received | 1999-02-19 |
| Date of Report | 1999-02-19 |
| Date Mfgr Received | 1999-01-22 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1999-03-01 |
| 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 | CIRCON ACMI TIMBERLAKE OBTURATOR |
| Generic Name | UROLOGICAL OBTURATOR |
| Product Code | FEC |
| Date Received | 1999-02-19 |
| Returned To Mfg | 1999-01-12 |
| Model Number | ETO-CFR27 |
| Catalog Number | ETO-CFR27 |
| Lot Number | * |
| ID Number | HZ (8/96) |
| 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 | 205298 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST NORWALK OH 448570409 US |
| Baseline Brand Name | CIRCON ACMI TIMBERLAKE OBTURATOR |
| Baseline Generic Name | UROLOGICAL OBTURATOR |
| Baseline Model No | ETO-CFR27 |
| Baseline Catalog No | ETO-CFR27 |
| Baseline ID | HZ (8/96) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-19 |