MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-19 for NOT KNOWN manufactured by Medtronic Ent.
[17433339]
The pt sent an email to the co website stating that in 2006, she started choking and spit out the broken tip of a sinus resector blade that was embedded within a blood clot. Pt reported no physical injury and included a photo of a fragment of what appears to be a medtronic ent sinus blade. The pt's physician at regional med ctr was contacted. The dr stated that during the pt's sinus procedure thirteen days earlier, a sinus blade quit working and was changed out, and he continued with the procedure. The procedure ended successfully.
Patient Sequence No: 1, Text Type: D, B5
[17668474]
The pt has agreed to meet with a co rep in order to evaluate the piece of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2007-00001 |
| MDR Report Key | 812608 |
| Report Source | 00 |
| Date Received | 2007-01-19 |
| Date of Report | 2007-01-19 |
| Date of Event | 2006-11-15 |
| Date Mfgr Received | 2006-12-22 |
| Date Added to Maude | 2007-02-07 |
| 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 | 3 |
| Manufacturer Contact | BILLY WIGGINS |
| Manufacturer Street | 6743 SOUTHPOINT DR. N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328196 |
| Manufacturer G1 | MEDTRONIC ENT |
| Manufacturer Street | 6743 SOUTHPOINT DR. N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOT KNOWN |
| Generic Name | DISPOSABLE SINUS MICRODEBRIDER & RESECTOR BLADE |
| Product Code | NLY |
| Date Received | 2007-01-19 |
| Returned To Mfg | 2007-01-18 |
| Model Number | NOT KNOWN |
| Catalog Number | NOT KNOWN |
| Lot Number | NOT KNOWN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800093 |
| Manufacturer | MEDTRONIC ENT |
| Manufacturer Address | * JACKSONVILLE FL 32216 US |
| Baseline Brand Name | LASER SHIELD II |
| Baseline Generic Name | ENDOTRACHEAL TUBE |
| Baseline Model No | NOT KNOWN |
| Baseline Catalog No | NOT KNOWN |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-19 |