MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-04-15 for ANGLED MICRONOSE ATTACHMENT QD11-S manufactured by The Anspach Effort, Inc..
[401924]
Customer stated cutters will not seat and dark fluid leaks out of the distal end.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2005-00056 |
| MDR Report Key | 593806 |
| Report Source | 07 |
| Date Received | 2005-04-15 |
| Date of Report | 2005-04-15 |
| Date of Event | 2005-04-08 |
| Date Mfgr Received | 2005-04-08 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2005-04-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM CONTEY |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGLED MICRONOSE ATTACHMENT |
| Generic Name | ATTACHMENT |
| Product Code | HBD |
| Date Received | 2005-04-15 |
| Returned To Mfg | 2005-04-12 |
| Model Number | QD11-S |
| Catalog Number | QD11-S |
| Lot Number | 51358636 |
| ID Number | * |
| 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 | 583646 |
| Manufacturer | THE ANSPACH EFFORT, INC. |
| Manufacturer Address | * PALM BEACH GARDENS FL * US |
| Baseline Brand Name | ANGLED MICRONOSE ATTACHMENT |
| Baseline Generic Name | ATTACHMENT |
| Baseline Model No | QD11-S |
| Baseline Catalog No | QD11-S |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-15 |